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

Model Number X SERIES

Device Problems Pacing Problem (1439); Defibrillation/Stimulation Problem (1573)

Patient Problem Necrosis (1971)

Event Date 11/28/2023

Event Type  Death  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to treat a 48-year-old male patient, the device displayed a "pace defib device failure" message.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including bench handling, impedance, and defib cycle testing without duplicating the report.An internal inspection of the device found no discrepancies.The device was recertified and returned to the customer.The battery used at the time of the report were not returned.Review of the logs showed the device is powered on and a "battery calibration required," prompt appears while not connected to auxiliary power.The battery calibration required message during device power on indicated that the device does not recognize the state of charge of the battery.This prompt continues throughout the log with multiple failed analysis attempts, pacer failures, charge failures, and defib failures being recorded throughout the event.The payloads associated with the errors in the json file indicate that the battery was below the 8v operating limit and could not charge the capacitor.Analysis of reports of this type has not identified an increase in trend.

• 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: 18334026
• MDR Text Key: 330551560
• Report Number: 1220908-2023-05011
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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: 48 YR
• Patient Sex: Male