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

Model Number X SERIES

Device Problems Arcing of Electrodes (2289); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Necrosis (1971)

Event Date 01/12/2021

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 defibrillate a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient's skin and an arc was seen from the electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.

Manufacturer Narrative

The device was returned to zoll medical united kingdom.The device was put through extensive testing including full functional testing with a focus on the defib testing with no discrepancies found.Review of the device log on the event date shows impedance measurements ranged from 61 ohms to 176 ohms.The increase in measured impedance, reported spark / arc, and the customer's statement that three sets of electrode pads were used are indicators of poor coupling between the patient and the pads.This report has been closed as poor coupling (continuity).The device was recertified and returned to the customer.The electrodes used at the time of the event were not returned for evaluation and are not zoll electrodes.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
• MDR Report Key: 11219359
• MDR Text Key: 257357598
• Report Number: 1220908-2021-00237
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K112432/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death