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

Model Number X SERIES

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Insufficient Information (4580)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to treat a 41-year-old male, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated the clinician exited aed mode and manually shocked the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned to zoll medical corporation, instead the clinical file was received.Review of the clinical file from the reported event concluded that the device worked as designed and within the limitations of the technology.Review of the clinical file identified conditions that qualify as a non-shockable event such as cpr waveform compressions were continued 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 "no shock advised" result.This claim has been closed as device meets specification.Analysis for 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: 18685847
• MDR Text Key: 335132773
• Report Number: 1220908-2024-00450
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946019143
• UDI-Public: 00847946019143
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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
• 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
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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 Age: 41 YR
• Patient Sex: Male