MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number R SERIES DEFIB

Device Problems Patient-Device Incompatibility (2682); Physical Resistance/Sticking (4012)

Patient Problem Skin Irritation (2076)

Event Date 10/31/2019

Event Type  malfunction  

Event Description

Zoll defib pads are causing skin integrity issues when removed 24 hours post-op.Confirmed with manufacturer that product is meant to stay on the patient for up to 24 hours or after 2 hours of continuous pacing.Zoll defib pads have been involved in 2 patient care events with skin tear/integrity concerns.Appropriate adhesive remover and site prep are being completed.When in use, the pads are being used with a zoll pacemaker/defibrillator product.Event 1: left lateral chest skin tear after cvs or case, presumed to be related to defib patch removal (cwon confirmed adhesive injury from removal of the defib patch).Event 2: defib pads were being changed during pt bath.Defib patch on back was removed using adhesive remover slowly.Skin was already impaired on bottom aspect of defib pad sticker (cwon confirmed adhesive injury to the right back from the defib pad).

• Brand Name: PRO PADZ
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 269 & 271 mill road; chelmsford MA 01824
• MDR Report Key: 9575320
• MDR Text Key: 174530760
• Report Number: 9575320
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: R SERIES DEFIB
• Device Catalogue Number: 8900-4006
• Device Lot Number: 0919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other