MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

Model Number 8900-0224-01

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

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), an arc was heard from the electrode pads and after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained burns.The customer was unable to provide information on the degree of the burn.

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Manufacturer Narrative

The complainant was contacted for return of the device.The electrode pads or information surrounding the electrode pads has not been retrieved by zoll for the purposes of this investigation.

• Brand Name: ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 16357567
• MDR Text Key: 309328137
• Report Number: 1218058-2023-00012
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other