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 08/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to defibrillate a (b)(6) year old male patient, a spark was seen and after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient sustained a second degree burn.

Manufacturer Narrative

The device was returned to zoll medical corporation.The reported malfunction was not replicated or confirmed.Review of the device logs found no shock events on the reported event date of (b)(6)2020.All other shock events were reviewed and found to be within specification and did not find any impedance discrepancies.The device was put through extensive testing including impedance calibration, defib cycling, and shock testing without duplicating a malfunction.The customer was unable to provide any additional information on the condition of the patient or patient preparation.The device was recertified and returned to the customer.The pads used at the time of the event were discarded and were unavailable for the investigation.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
• MDR Report Key: 10554608
• MDR Text Key: 207562364
• Report Number: 1220908-2020-02912
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017200
• UDI-Public: 00847946017200
• Combination Product (y/n): N
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR