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

Model Number 8900-2101-01

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event 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.

Manufacturer Narrative

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

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
• Type of Device: 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
• MDR Text Key: 334097368
• Report Number: 1218058-2024-00007
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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