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

Model Number AED PRO

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

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 patient (age & gender unknown), 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

The device was not returned to zoll medical corporation for evaluation.Instead, the ecg data from the event was returned to zoll for evaluation.Our review of the data found that the device performed to specification.The first analysis, segments two and three, as well as the second analysis, segments one and two; showed "no matching condition".No matching condition results are due to the measurements of the waveforms not matching predefined measurements for shockable and non shockable rhythms.For segment two, there were some low amplitude peaks which made detection difficult for the algorithm and contributed to some of the other measurements not matching.The algorithm was unable to calculate average width of the ecg as well as being unable to detect an accurate rate.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.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: AED PRO
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 12683519
• MDR Text Key: 277961941
• Report Number: 1220908-2021-03496
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110526
• 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: 10/01/2021

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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