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

Model Number X SERIES

Device Problems Failure to Deliver Shock/Stimulation (1133); Sparking (2595)

Patient Problem Cardiac Arrest (1762)

Event Date 03/13/2024

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 defibrillate a patient (age & gender unknown) in cardiac arrest, the device successfully delivered one shock.The device then failed to discharge a second shock.A new set of electrode pads were applied to the patient and the selected energy was delivered.However, on a subsequent shock there was a spark seen from the pads.The electrodes were replaced again to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical united kingdom evaluated the device for the report of unable to discharge and sparked.The device was put through extensive testing including functional testing, defib/pacer stress testing, bench handling, and defib cycling without duplicating any malfunction to the device.The device was recertified and returned to the customer.The log showed the device is charged but is in a defib lead fault state before being able to discharge on the third attempt.A defib lead fault indicates an invalid patient impedance but was ultimately achieved based on the delivery of therapy on the third shock attempt.This third shock to the patient indicated poor coupling which likely led to the spark observed.Poor coupling can be caused by various factors including but not limited to electrode placement, poor patient preparation, or just poor contact between the pad and patient.Poor coupling can lead to air pockets forming between the electrodes and the patient which can cause sparking, burning smell, and pop sound.The x series operator's guide states, 'do not use therapy or ecg electrodes if the gel is dried, separated, torn, or split from the foil; patient burns may result from using such electrodes.Poor adherence and/or air pockets under therapy electrodes can cause arcing and skin burns.' 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: 19191659
• MDR Text Key: 341145989
• Report Number: 1220908-2024-01603
• 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: 04/12/2024

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: 04/12/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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