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

Model Number	610-0221511-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 during biomed testing the device was unable to detect the attached pads and multifunction cable.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the device and the device performed to specification.The device passed the final test and was recertified and returned to the customer.Review of the device activity log showed the user was utilizing closed onestep complete pads for testing or troubleshooting.The device was not connected to an ecg cable, as all logs recorded ecg cable id as "3".Upon power-up, the device detected a "short detected" condition.The logs showed the end user powering up in pacer mode without a manual test being performed.The device entered pacer mode without an ecg cable connected.In pacer mode, the x series monitor automatically switches to lead view (leads i, ii, or iii), which requires an ecg cable.Without it, the device appropriately displayed a 'lead fault' message.This message can only be cleared by connecting an ecg cable with a patient or simulator in pace mode, or by switching the device back to defib mode.The device functioned as designed, and the messages observed were consistent with how the device responds when used in pacer mode without an ecg cable.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: 22395013
• Report Number: 1220908-2025-02356
• Device Sequence Number: 9104768
• Product Code: MKJ
• UDI-Device Identifier: 00847946014964
• UDI-Public: (01)00847946014964
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/16/2025

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: 610-0221511-01
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2016
• 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