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

Model Number X SERIES

Device Problem Smoking (1585)

Patient Problem Chest Pain (1776)

Event Date 05/18/2023

Event Type  malfunction  

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 monitor a 17-year-old female patient, they observed a very small amount of smoke coming from the attached ecg electrodes.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The device and ecg monitoring leads were returned to zoll medical united kingdom for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing including electrical safety testing using the customer's returned leads without duplicating the report.An internal inspection of the device found no discrepancies.The ecg monitoring leads were discarded as a precaution.The device was recertified and returned to the customer.It is important to note that ecg leads are not a current pathway and do not deliver energy.No trend is associated with reports of this type.

• 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: 17083107
• MDR Text Key: 316727553
• Report Number: 1220908-2023-02138
• 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: 05/23/2023

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: 05/23/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: 17 YR
• Patient Sex: Female