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

Model Number AED PRO

Device Problems Use of Device Problem (1670); Failure of Device to Self-Test (2937)

Patient Problem Necrosis (1971)

Event Date 04/05/2021

Event Type  Death  

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 defibrillate a patient (age & gender unknown), after one shock was delivered, the device displayed an unknown "out of order" message.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), after one shock was delivered, the device prompted a "unit failed" message.Complainant indicated that the patient subsequently expired, however it was not a result of 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 b5 and h6 (device code).Device evaluation: zoll medical canada evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including full functional testing and defib stress testing using a test set of pads without duplicating the report.The device was recertified and returned to the customer.Review of the device activity logs did not show any faults that could be associated with customer report.Review of the log did indicate the pads became loose during the patient event after delivering a shock.The pads were not returned to zoll for evaluation.The part number and lot number of the pads were not provided by the customer.No trend is associated with reports of this type.

• Brand Name: AED PRO
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11678802
• MDR Text Key: 245795950
• Report Number: 1220908-2021-01310
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death