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

Model Number R SERIES

Device Problem Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), a spark was seen coming from the attached electrode pads after delivering the shock to the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Manufacturer Narrative

The device was returned to zoll medical corporation for evaluation.The device was put through extensive testing without duplicating the report.Review of the device log indicates several pads related messages at the time of the shock event, as well as a large difference between the measured impedances.This is evidence of poor coupling between the patient and the electrodes being used.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Zoll recommends that patients are cleaned and hair is clipped prior to applying electrode pads to assure good coupling of electrode to skin contact.Poor adherence and/or air under the electrodes can lead to the possibility of arcing and skin burns.The event electrode pads were not returned as part of the investigation.The device was recertified and returned to the customer.Analysis of 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
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 14516045
• MDR Text Key: 292801501
• Report Number: 1220908-2022-01888
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017446
• UDI-Public: 00847946017446
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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