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 03/08/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to defibrillate a 95-year-old male patient, the device gave a "no shock advised" prompt for a rhythm clinicians believed was shockable.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

Zoll medical united kingdom evaluated the device and the device performed to specification.A review of the device log confirms the patient was in a non-shockable rhythm for the entirety of the case.16 analyses were performed, however the 12th analysis event resulted in a shock advised prompt due to the user performing cpr during the analysis.The device was recertified and returned to the customer.Prior to analysis, the x series displays an "analyzing ecg" message for five seconds and alerts the user with audible and visible "stop cpr.Do not touch patient, analyzing" messages.After the analysis is complete the device will give a prompt to continue cpr.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: 16567990
• MDR Text Key: 311528605
• Report Number: 1220908-2023-00978
• 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: 03/09/2023

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: 95 YR
• Patient Sex: Male