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

Model Number	620-2271511-01
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to pace a 71-year-old male patient, the device was unable to pace.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference sections d4 model # updated, d4 catalog # removed, d4 primary udi # updated.Evaluation results: zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including all functional testing, impedance, defib/pacer stress testing, bench handling, and defib cycling without duplicating the report.The device was recertified and returned to the customer.Review of the device's log file did not show any faults associate to a device failure.No trend is associated with reports of this type.It's noteworthy to mention, the x-series operator's guide states that proper demand pacing requires a reliable, high-quality surface ecg signal.For best results apply both standard ecg monitoring electrodes and hands-free pacing therapy electrodes to the patient.Without connecting hands-free pacing therapy electrodes to the patient, the device cannot pace the patient.

• 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: 19448450
• Report Number: 1220908-2024-01971
• Device Sequence Number: 12896572
• Product Code: MKJ
• UDI-Device Identifier: 00847946019778
• UDI-Public: (01)00847946019778(21)AR20I051165
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/15/2024

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: 620-2271511-01
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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: 71 YR
• Patient Sex: Male