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

Model Number R SERIES

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 02/03/2024

Event Type  Injury  

Event Description

Complainant alleged that while attempting to perform manual cpr on a patient (age & gender unknown), two staff member's received burns of an unknown degree on their hands.Complainant indicated the staff memebers were sent to the emergency room after the event but did not have additional information regarding treatment/degree of burns.

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 and one step cable were returned to zoll medical corporation for evaluation.The defib pads used during the event were not returned.The customer's report was not replicated or confirmed.The device was put through extensive testing including full functional testing, hipot, and leakage testing without duplicating the report.An internal inspection of the device found no discrepancies.The activity log recorded a patient impedance of 120 ohms and a defib impedance of 115 ohms.This does not confirm whether the operator was in contact with the pads during a discharge, but it shows that there was proper coupling between the pads and the patient.The degree of burn is not known, and no pictures were received.There is no evidence to confirm or deny that the operators felt something during compressions, however device testing and log review indicate that it was not related to a discharge or device malfunction.The device was recertified and returned to the customer.The operation guide recommends that before discharging the defibrillator, warn everyone to stand clear of the patient.No trend is associated with reports of this type.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 18788344
• MDR Text Key: 336330319
• Report Number: 1220908-2024-00659
• Device Sequence Number: 1
• Product Code: MKJ
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/14/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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