MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR AA, SINGLE

Model Number	8900-0225-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to pace a 77-year-old female patient, after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a burn.The customer was unable to provide information on the degree of the burn.
Additional Manufacturer Narrative
The electrodes were not returned to zoll medical corporation for evaluation.The customer's report was observed and attributed to incorrect use of device during review of provided information.The customer utilized the pads for pacing for 18 hours during the event.However, as per the ifu, the pads are recommended to be check every 30 minutes and replaced after 8 hours of use to maximize patient benefit.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, ONESTEP CPR AA, SINGLE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 17714959
• Report Number: 1218058-2023-00139
• Device Sequence Number: 19370446
• Product Code: MKJ
• UDI-Device Identifier: 00847946016289
• UDI-Public: 00847946016289
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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
• Operator of Device: Other
• Device Model Number: 8900-0225-01
• Device Catalogue Number: 8900-0225-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White