MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP; DEFIB/PACING ELECTRODE

Model Number 8900-4005

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), after removing the electrode pads burns were found on the patient's skin.No additional information could be provided regarding the subsequent treatment of the burn.

Manufacturer Narrative

The customer returned three sets of pro padz to zoll medical corporation for evaluation.One set was opened and used during the patient event, one was open and unused, and one was unopened.The open and used set of pro padz passed continuity testing.During visual inspection the technician noted there is a clear sign of an air pocket/bubble that was trapped between the pads and patient?s skin, leading to poor coupling during therapy.Hair and skin cells were also observed during inspection which can contribute to sparking, arcing, and burns.The customer also stated the event occurred in an oxygen-rich environment which can also contribute to the customer?s observations.Electrode labeling provides instructions for proper electrode application techniques.Poor coupling due air trapped under the electrodes has the potential to cause arcing and skin burns.Proper skin preparation and application techniques do not guarantee burns will not occur and burns from defibrillation are a known potential risk.The pads were scrapped after testing and the customer was sent replacement pads.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: PRO PADZ, MFE, RADIOLUCENT, ADULT, HVP
• Type of Device: 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: 18394503
• MDR Text Key: 331330736
• Report Number: 1218058-2023-00179
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016661
• UDI-Public: 00847946016661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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
• Device Operator: Other
• Device Expiration Date: 06/03/2024
• Device Model Number: 8900-4005
• Device Catalogue Number: 8900-4005
• Device Lot Number: 2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 12/05/2023
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other