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

Model Number R SERIES

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

Patient Problem Burn(s) (1757)

Event Date 05/17/2021

Event Type  Injury  

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 female patient (age unknown), after removing the electrode pads, burns were found on the patient's skin and an arc was heard from the electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Patient sustained burnmarks.

Manufacturer Narrative

The device was returned to zoll medical united kingdom.The device was put through extensive testing including defib testing without duplicating the report.The device was recertified successfully and returned to the customer.Review of the device logs showed several shocks, one of these shocks had a significant difference between the patient and defib impedance measurements and delivered 333j.The measurements corroborate the users report that ecg electrodes were left under the defib pads at the time of the shock causing poor coupling between the patient and the electrode.The r series operator's guide provide clear instruction on patient preparation "ensure that the electrodes are making good contact with the patient's skin and are not covering any part of the ecg electrodes".The customer stated that after the spark, the electrodes were replaced but they could not get a good clean signal.The monitoring electrode was replaced along with the second set of electrodes and the device worked as expected for the remainder of the event.It is noteworthy to mention the electrode pads used at the time of the reported event were not returned for evaluation.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11939523
• MDR Text Key: 254289206
• Report Number: 1220908-2021-01890
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other