Traceability for defibrillators and cardioverters with Lown

Ilustração conceitual: Coração estilizado, linha gráfica e documento representam desfibrilação e seus registros.

By Arkmeds

Traceability in defibrillator and cardioverter servicing means being able to connect the device assessed, the work performed, the results and the recorded conclusion. Lown, the Arkmeds analyzer, provides functions for assessing energy, synchronization, charge time and pacemaker functions, as well as simulating ECG signals. Its connection to Mark II allows this work to be integrated with checklists and PDF reports. Explore Lown.

To make effective use of this integration, documentation needs to preserve the context of the service. A set of values becomes useful when the team can identify its source, understand the scope and locate any outstanding issues. This article focuses on organizing that information; test procedures must follow the applicable manuals and references.

Start with the identity of the device

Before considering the service history, confirm how each unit is identified. The model, serial number and asset ID must refer to the same asset across the records used by the team. When several devices are similar, the product name alone may leave uncertainty about which unit was serviced.

Review how the asset record reflects changes in location, accessory replacements and relevant updates. The aim is to allow someone who was not involved in the work to identify the device and understand the context described in the work order.

A measurement linked to the wrong asset undermines the usefulness of the history, even if the result was transferred correctly to the document.

Defibrillator readiness involves the device, its accessories and access

A study of annual inspections of public automated external defibrillators (AEDs) in Seoul, South Korea, analyzed 23,619 records from 2013 to 2017. In 3,646 of those records, or 15.4%, the AED was classified as not ready for use because of a functional problem, a battery issue and/or expired electrode pads. The count combines inspections across multiple years: it must not be presented as 23,619 unique devices or as the probability of failure during an emergency. The study was limited to city-funded devices and did not assess hospital cardioverters in Brazil. Read the on-site inspection study.

For traceability, the practical lesson is to distinguish device performance assessment from readiness management. Depending on the model and the applicable procedure, track identification, accessories, replacement deadlines, location, recorded condition and outstanding issues. A test report addresses the work performed within its stated scope; availability for patient care also depends on items and conditions that need their own follow-up. This research helps frame management questions. It does not establish that any particular analyzer or software reduces clinical events.

Keep the scope connected to the results

The scope must clearly state which functions were assessed during the service. The presence of a feature on the analyzer does not mean it was used on every job. The technical report must describe what was actually done.

When reviewing the documentation template, check whether it allows the team to record:

  • Identification of the asset, the service and the professional responsible.
  • The instrument used and a reference to the procedure followed.
  • The functions assessed and their corresponding results.
  • Conditions or observations needed to interpret the record.
  • Items not performed, limitations and outstanding issues.
  • The technical conclusion and next steps required by the institution’s process.

The responsible team must define the specific fields and criteria. This outline does not establish test parameters, tolerances, connections or decisions about clinical use.

When documenting an exception, provide enough detail for the next person to continue the work. “Check later” leaves a task open; a clearly identified issue with an assigned owner and next steps can be tracked through to resolution.

Combine digital integration with document review

Lown offers Bluetooth connectivity with Mark II and offline operation with later synchronization, as described on the official product page.

Include a review step after data collection. Confirm that the results belong to the correct work order and that the necessary observations are included in the document. Integration can reduce manual transcription and support consistent records. The team’s observations remain necessary to explain situations encountered during the service.

If the work was performed without internet access, also track synchronization. Both the team that performed the work and the report recipient need to know when the record is available on the platform. This helps avoid announcing delivery before the document can be accessed.

Use the service history to ask better questions

Arkmeds CMMS brings together work orders and service history by asset, providing a reference point for following records over time. Explore the CMMS.

When reviewing a service history, start with the questions the documentation should answer. Were there outstanding issues at the previous service? Were they addressed? Has the scope changed? Are the records comparable? Is any missing information still needed?

Take care when comparing results from different periods. The technical team must consider changes in procedures, test conditions or recording methods. A numerical difference needs context before it can be interpreted as a performance trend.

For administrative monitoring, management can track incomplete documents, report delivery time and the number of open issues. These indicators help assess the documentation process without replacing the assessment of the device itself.

Video on preventive maintenance and calibration

On January 20, 2025, the Arkmeds channel published a video on preventive maintenance and calibration of defibrillators and cardioverters. The presentation covers energy, synchronization, ECG, work orders and technical reports. The Lown chapter begins at 01:25. The video is in Brazilian Portuguese.

The video can help viewers become familiar with the solution. To perform the service, consult the relevant documentation, including the analyzer manuals section, and follow the qualified team’s procedure.

Frequently asked questions

Is traceability just about keeping the PDF?

Keeping the document is one part of it. You must also be able to connect it to the asset, the service, the people responsible and the context of the results.

Does every service need to assess every function available on Lown?

The scope depends on the device and the applicable procedure. The record must identify what was actually assessed and any relevant limitations.

How should an outstanding issue found during review be handled?

Record the issue and refer it to the person responsible under the institution’s process. Do not finalize the documentation as though the matter has already been resolved.

Discuss your team’s documentation needs

Contact Arkmeds to learn about Lown and its integration with Mark II. Bring examples of your operation’s needs for recording, reviewing and following up on service information.