MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number R SERIES

Device Problem Unexpected Shutdown (4019)

Patient Problem Necrosis (1971)

Event Type  Death  

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 pace a patient (age & gender unknown), the device inappropriately shut down.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Communication with the customer indicates the device shutdown due to a low battery.The device was not connected to ac power at the time of the event.The battery was replaced by the customer and the device was returned to service.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• 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: 17887744
• MDR Text Key: 325127019
• Report Number: 1220908-2023-03824
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017217
• UDI-Public: 00847946017217
• 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: 09/18/2023

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: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 01/15/2024
• 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
• Patient Outcome(s): Death