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

Model Number X SERIES

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Cardiac Arrest (1762)

Event Date 03/07/2024

Event Type  Death  

Event Description

Complainant alleged that while attempting to defibrillate a 60-year-old female patient, the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Manufacturer Narrative

The device was returned to zoll medical united kingdom for evaluation and the device performed to specification.A review of the device log shows there were two "shock advised" events.Both analysis events recorded cpr waveform activity throughout the analysis period which introduced significant artifact into the ecg.The presence of this artifact obscured the underlying rhythm and shifted the analysis results to a "shock advised" result.The device charged on both prompts; however, they were not delivered as aed mode was manually exited which disarms the charged device.All analyses during the case started at the correct interval and the device recorded advisory prompts.The device was put through extensive functional testing including shock functionalities without duplicating any fault to the device.Bench handling with the returned multifunction cable observed noise on the ecg, the multifunction cable was scrapped as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• Type of Device: 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: 19133403
• MDR Text Key: 340484398
• Report Number: 1220908-2024-01501
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: X SERIES
• Device Catalogue Number: X SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Sex: Female