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

Model Number AED PLUS

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2023

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the clinical file of the customer's report was provided.Review of the clinical file did show the customer's report.The waveform measurements in segments 2 and 3 fell within the range of measurements defined for vf.The percentages of detected peaks with similar amplitudes were 64% and 65% for segments 2 and 3 where the defined upper limit is less than 66%.The number of peaks detected in segments 2 and 3 was 11 for each segment and the algorithm matching definition is looking for a value of greater than 10.In each instance, these measurements are borderline and resulted in a false positive result of shock advised.The aed operated as designed and within the limitations of the technology.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AED PLUS
• 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: 18380862
• MDR Text Key: 331187908
• Report Number: 1220908-2023-04847
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 04560233596016
• UDI-Public: 04560233596016
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011541/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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: AED PLUS
• Device Catalogue Number: AED PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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