MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, PRO-PADZ CARDIOLOGY W/LVP GEL, SINGLE

Model Number	8900-2101-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleged that while attempting to treat a patient during open heart surgery (age & gender unknown), tegaderm (film dressing) is applied over the pro-padz.After removing the tegaderm and pro-padz, tears were found on the patient's skin.No information was provided about subsequent treatment for the skin tears oberved.
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The electrode pads were not returned to zoll medical corporation for evaluation.Communication with the customer indicated the current process being utilized at their location, believes the skin tears observed in the complaint were due to the placement of the tegaderm (later determined to be suresite) over the pads.The cardiology pro-padz have been used in conjunction with a film dressing which has caused tearing in multiple patients skin during therapy.The film dressing was used to prevent the pads from becoming damp while the patient was prepped; however, this method is considered off label use of the product.The customer was then contacted by zoll medical pawtucket engineer and sales teams.The teams provided direction and insight as to how other hospitals kept the pads dry.The zoll team discouraged the use of any products over the pads.It's noteworthy to mention, the ifu warns that pads should be used "only with zoll pacemaker/defibrillator products" and recommends that the user "wipe off excess moisture/diaphoresis with a dry cloth." analysis for reports of this type has not identified an increase in trend.

• Brand Name: ELECTRODES, PRO-PADZ CARDIOLOGY W/LVP GEL, SINGLE
• Common Device Name: 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: 18606369
• Report Number: 1218058-2024-00007
• Device Sequence Number: 2747017
• Product Code: MKJ
• UDI-Device Identifier: 00847946016395
• UDI-Public: 00847946016395
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/09/2024

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: 8900-2101-01
• Device Catalogue Number: 8900-2101-01
• Was Device Available for Evaluation?: No
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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