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

Model Number R SERIES

Device Problems Sparking (2595); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); No Information (3190)

Event Date 08/28/2019

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 defibrillating a patient (age & gender unknown), they observed a spark from the device, then after removing the electrode pads, burns were found on the patient.The customer was unable to provide what degree burn the patient received.Patient sustained burnmarks.

Manufacturer Narrative

The device and electrode pads were returned to zoll medical corporation and the customer report was not confirmed or observed.The device was put through extensive testing which included bench handling, energy output testing, and patient impedance calibration without introducing a high impedance condition that would be consistent with the report.Evaluation of the electrodes showed some evidence of arching on the conductive plate of the front pad, however, the back pad had very faint arching at the corners of the conductive gel.Visual inspection found several strands of human hairs mostly on the front pad.No pictures of the reported burn were provided.The evidence is consistent with poor coupling between the patient and the pads.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Patient burns can be associated outcome with defibrillation events and is identified in labeling as an executed risk.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
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 9088644
• MDR Text Key: 159201652
• Report Number: 1220908-2019-02755
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017200
• UDI-Public: 00847946017200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559/P160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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: 09/09/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• 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
• Patient Outcome(s): Other