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

Model Number	610-2231411-01
Medical Device Problem Codes	No Display/Image (1183); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to monitor a patient (age & gender unknown) the device displayed a black screen.Complainant indicated that the clinician obtained new leads and restarted the device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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 section b5 and h6 (medical device problem code).This report was inadvertently submitted and reports of this nature are typically not submitted as there would be no potential for clinical impact.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 ecg stress testing and bench handling without duplicating the report.During evaluation it was observed the mp/pp software had been updated but the cp software remained on an older version, resulting in a software incompatibility.This mismatch in software versions can lead to issues with 12 lead ecg functionality.An internal inspection resulted in no findings.The communication software was upgraded to the appropriate version.The device was recertified and returned to the customer.No trend is associated with reports of this type.
Event or Problem Description
Complainant alleged that while attempting to monitor a patient (age & gender unknown) the device's 12 lead was not functioning.Complainant indicated that the clinician obtained new leads and restarted the device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

• 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: 21525889
• Report Number: 1220908-2025-00675
• Device Sequence Number: 8378675
• Product Code: MKJ
• UDI-Device Identifier: 00847946004378
• UDI-Public: (01)00847946004378
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/12/2025

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: 610-2231411-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Sex: Unknown