MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED3; DEFIBRILLATOR

Model Number AED3

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a 5-year-old male patient, the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.The clinician subsequently administered the shock to the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.The clinical file indicated that the three analysis ecg waveform results were influenced by motion artifacts.Based on our review of the data we have concluded that the analysis program worked within its limitations and that there was no indication of a malfunction with the device.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED3
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 16636589
• MDR Text Key: 312238161
• Report Number: 1220908-2023-01083
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946020064
• UDI-Public: 00847946020064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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: AED3
• Device Catalogue Number: AED3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Male