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

Model Number	X SERIES
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/03/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to defibrillate an 85-year-old male patient, the device failed to charge.Complainant indicated that the patient subsequently expired; however they do not believe this was device associated.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive debug and final testing without duplicating the report.The device was recertified and returned to the customer.Review of the device logs confirmed that on the fifth charge attempt, the device charging timed out related to insufficient energy from the battery.The battery is suspected as the cause based on the log review but was not returned as part of the investigation.This information has been communicated to the customer.No trend is associated with reports of this type.

• Brand Name: X SERIES
• Common Device Name: 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: 17808303
• Report Number: 1220908-2023-03670
• Device Sequence Number: 20515219
• Product Code: MKJ
• UDI-Device Identifier: 00847946006013
• UDI-Public: 00847946006013
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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
• Operator of Device: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 85 YR
• Patient Sex: Male