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	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to pace a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the clinician obtained another device to continue treating the patient.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
Zoll medical corporation evaluated the electrodes and the electrode pads performed to specification.Visual evaluation showed the pads were stuck to the correct side of the styrene liner.The pads were visually inspected and appeared typical.The electrode pads were scrapped.Review of the provided visual data confirmed reddening/burn on the patient.The burn indicates a tremendous amount on how the patient was burned.The electrodes do not appear as if they were rolled on, and the application resulted in large folds in the gel, generating an air pocket and in turn leading to a higher probability of a patient skin burn.The air trapped in-between the gel and tin is due to the poor application of the electrodes.Poor application led to the burns and visual air pockets in between the gel and tin.The ifu instructs users to remove excess hair and ensure skin is clean and dry under the electrode.Excessive hair and debris/moisture can inhibit good coupling, leading to the possibility of arcing and skin burns.This report has been attributed to poor coupling of the electrode pads to the patient's skin.Analysis of 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: 16611070
• Report Number: 1218058-2023-00063
• Device Sequence Number: 17376349
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: 07/30/2024
• Device Model Number: 8900-4004
• Device Catalogue Number: 8900-4004
• Device Lot Number: 3122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown