MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PRO; DEFIBRILLATOR

Model Number AED PRO

Device Problems Incorrect Interpretation of Signal (1543); Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that while attempting to treat a (b)(6) male patient, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section a1, a2, a4, b5, and h6 (medical device problem code and health effect impact code).Evaluation results: the device was returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The device passed full functionality and stress testing without duplicating the report.The device recognized all signals during testing with an analyzer.Review of the device log found no indication of any errors related to the report.The logs cannot confirm that what was shown on the screen differed from what was recorded into the data file.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.Reports of this nature are typically not submitted as there would be no potential for clinical impact.

Event Description

Complainant alleged that during functional testing, the post-event case review data differed from the event ecg content shown on the screen.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: AED PRO
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11642521
• MDR Text Key: 244681381
• Report Number: 1220908-2021-01084
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K110526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AED PRO
• Device Catalogue Number: AED PRO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR