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

Model Number 8900-4004

Device Problem Compatibility Problem (2960)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

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

Event 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.

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
• Type of Device: DEFIB/PACING ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11448658
• MDR Text Key: 238838942
• Report Number: 1218058-2021-00033
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016456
• UDI-Public: 00847946016456
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900-4004
• Device Catalogue Number: 8900-4004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other