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

Model Number	630-2241212-01
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to pace an 89-year-old patient (gender unknown), the device was unable to adjust pace current.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was evaluated by a zoll field representative at the customer's facility.The customer's report could not be replicated.The device passed all functional testing.Review of the clinical event file showed the deviced entered pace mode and began pacing, though pacer settings had not yet been increased.The ecg signal displayed artifacts, and an ecg fault was logged.At that moment, the device reported a "pacer output out of range" message, indicating the output was outside the 12.5% tolerance of the set current.The log intermittenly recorded ecg faults corresponding to noisy ecg signals, which may have been caused by issues such as poor electrode coupling, patient movement, or pad placement.The event pads were not available for evaluation.The device was recertified and returned to clinical use.Analysis of reports of this type has not identified an increase in trend.

• 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: 22122792
• Report Number: 1220908-2025-01896
• Device Sequence Number: 4122578
• Product Code: MKJ
• UDI-Device Identifier: 00847946029661
• UDI-Public: (01)00847946029661
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 630-2241212-01
• Was Device Available for Evaluation?: No
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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
• Patient Age: 89 YR
• Patient Sex: Unknown