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

Model Number X SERIES

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Necrosis (1971)

Event Date 11/15/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a 76-year-old female patient, the device issued a "shock advised" prompt for a heart rhythm they believed was non-shockable.Complainant indicated that the patient subsequently expired.However, it was not a result of the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the clinical data files were provided for review.Our evaluation of the clinical files determined that cpr was being performed during the rapid shock analysis period.This resulted in a "shock advised" being recommended.Cpr should be stopped and contact with the patient ceased during an analysis period.Our analysis concluded that the device worked to specification.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: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 15954888
• MDR Text Key: 305231738
• Report Number: 1220908-2022-04841
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946006389
• UDI-Public: 00847946006389
• 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
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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
• 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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/09/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2017
• 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 Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Female