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

Model Number	620-2431411-01
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Tachycardia (2095)
Date of Event	01/23/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to cardiovert a female patient (age unknown), the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that the patient subsequently expired.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation where the clinical file analysis was reviewed for each outcome.The device was recertified and returned to the customer.Review of the clinical data logs showed analysis events 1 and 3, the algorithm determined the presenting waveforms as non-shockable forms of ventricular tachycardia, mostly due to low rate and wide complexes.Analysis event 2, 21 and 23 were rapid shock events that were determined to be non-shockable.Also presenting ventricular tachycardia with low rate and wide complexes.Analysis events 4 and 19 were rapid shock events which did result in shockable decisions.However, the shock conversion estimator (sce) feature was enabled, which overrode the decision to shock in each analysis event.The sce function looks at the waveform spectrally and determines its probability to be converted to an organized rhythm.The sce will override the shock advisement and result in a no shock advised even if the majority or all segments of the analysis point to shockable.In both analyses, the algorithm altered its shock decision based on sce and reversed its shock decision.Based on our review of the data we have concluded that the analysis program worked as designed within its limitations and there was no indication of a malfunction with the device.No trend is associated with reports of this type.

• 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: 21374640
• Report Number: 1220908-2025-00479
• Device Sequence Number: 8549798
• Product Code: MKJ
• UDI-Device Identifier: 00847946019464
• UDI-Public: (01)00847946019464
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/23/2025

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: Other
• Device Model Number: 620-2431411-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female