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

Model Number	630-2431211-01
Medical Device Problem Codes	Failure to Charge (1085); Delayed Charge Time (2586)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2024
Type of Reportable Event	Death
Additional 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 without duplicating the report.An internal inspection of the device found no discrepancies.Review of the device log found entries related to the customer's report.Following the "charge error" message the user was able to successfully charge the device five more times and deliver a 120j shjock and 150j shock to the patient.Seven subsequent charge attempts were unsuccessful.The log indicates the device was being operated on battery power only and the battery voltage dropped below the minimum required voltage.The returned battery was observed to be four years old and the battery log suggests this battery was not used in the patient event.The battery was scrapped and the customer will be given a replacement battery.The device will be recertified and returned to the customer.Per the surepower battery pack guide (pn: 9650-0536-01) (rev: f), "for all battery packs older than three years, zoll recommends manual testing and recalibration every three months." the x series operator's guide (pn: 9650-005355-01) (rev: d) also speaks to the criticality of having a back-up power source when using the device and instructs the user to "always carry at least one fully charged spare battery.If no other source of back-up power is available, two spare batteries are advisable." no trend is associated with reports of this type.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a 57-year-old female patient, after shocking the patient a couple of times, the device displayed a "defib charging error" message six times and the device took an extended time to charge energy.Complainant indicated that the patient subsequently expired.

• 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: 20896012
• Report Number: 1220908-2024-04378
• Device Sequence Number: 12738315
• Product Code: MKJ
• UDI-Device Identifier: 00847946029586
• UDI-Public: (01)00847946029586
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: 630-2431211-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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: 57 YR
• Patient Sex: Female