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

Model Number AED PRO

Device Problems Failure to Deliver Shock/Stimulation (1133); Failure of Device to Self-Test (2937)

Patient Problem Asystole (4442)

Event Date 12/22/2023

Event Type  Death  

Event Description

Complainant alleged that while attempting to treat a patient in their 80's (gender unknown), the device prompted a "unit failed" message.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

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

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 problem code).The device was returned to zoll medical corporation for evaluation.The customer's report was verified and attributed to a loose digital to analog interconnection cable.The cable was resecured to remedy the report.It is unknown what caused the cable to become loose; however, during evaluation, the force required to loosen the cable was likely an indication of an impact to the device outside of normal handling.No physical damage was noted to the outside of the device and there is no information available on customer storage and handling of the device.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that while attempting to treat a patient in their 80's (gender unknown), the device was unable to discharge.Complainant indicated that the patient subsequently expired.

• Brand Name: AED PRO
• 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: 18517573
• MDR Text Key: 332922818
• Report Number: 1220908-2024-00022
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160022
• 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: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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
• Patient Outcome(s): Death