MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ HVP MULTI FUNCTION ELECTRODES; DEFIB/PACING ELECTRODE

Model Number	8900-4004
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), after removing the electrode pads burns were found on the patient's skin.The customer was unable to provide information on the degree of the burn.
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Additional Manufacturer Narrative
The stat padz used during the event were returned to zoll medical corporation for evaluation.The pads were visually inspected and noted hair stuck to the front pad.The pads passed continuity testing.It is important to note that during defibrillation therapy, patients can experience burns and redness due to a high measured patient impedance.This could be for a variety of reasons including, but not limited to, skin preparation, electrode application, or poor coupling.Zoll recommends that patients are cleaned and clipped prior to applying electrode pads to assure good coupling of electrode to skin contact.Poor coupling appears to be a factor in this patient event.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: STAT PADZ HVP MULTI FUNCTION ELECTRODES
• Common Device Name: DEFIB/PACING 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: 16857553
• Report Number: 1218058-2023-00093
• Device Sequence Number: 20964326
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/11/2023

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 Expiration Date: 05/14/2024
• Device Model Number: 8900-4004
• Device Catalogue Number: 8900-4004
• Device Lot Number: 2022A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2022
• 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 Sex: Unknown