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

Model Number	8900-4004
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Skin Tears (2516)
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 cardiovert a patient (age & gender unknown), upon removal of the electrode pads, tearing of the skin with skin removal was found on the patient.Complainant indicated that the patient sustained tearing of the skin upon removal of the electrode pads.
Additional Manufacturer Narrative
The stat padz were not returned to zoll medical corporation for evaluation.Instead, pictures of the customer's report were provided.Review of the pictures did show evidence of skin tears.However, without receipt of the pads, a root cause cannot be determined.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
• MDR Report Key: 11448658
• Report Number: 1218058-2021-00033
• Device Sequence Number: 11765809
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/16/2021

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: 8900-4004
• Device Catalogue Number: 8900-4004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other