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

Model Number X SERIES

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Necrosis (1971)

Event Date 03/10/2024

Event Type  Death  

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing including bench handling, defib cycling, and battery testing without duplicating the report.An internal inspection of the device found no discrepancies.The log shows the device recognized a battery recalibration condition.This is not an indication of a device malfunction, but that the battery needs to be calibrated to the capacity it can supply based on factors like age.The battery nor any other cables or accessories were returned for evaluation.The battery connection hardware was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.

Event Description

Complainant alleged that while attempting to defibrillate 54-year-old male patient, the device was charged to 190 joules but failed to discharge.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

• Brand Name: X SERIES
• 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: 19007551
• MDR Text Key: 338951460
• Report Number: 1220908-2024-01113
• Device Sequence Number: 1
• Product Code: MKJ
• 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
• Report Date: 03/11/2024

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: Health Professional
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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
• Patient Age: 54 YR
• Patient Sex: Male