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

Model Number 8900-4006

Device Problem Device Emits Odor (1425)

Patient Problem Burn, Thermal (2530)

Event Date 01/24/2020

Event Type  malfunction  

Event Description

This is the second time an event has occurred with the pro-padz in use with a cardioversion patient.First patient also in pacu for cardioversion.After cardioversion and on removal of pads, there was noted to be a small burn on patients chest along the edge of where pad was, approx 1.5 cm long, 1mm wide.Second event is being submitted now that we have set of pads, cardioversion was successful after one attempt.Removed anterior defib pad a burning smell was noted.Patient had red circular marks on her chest in shape of the pads as well.No skin appeared blistered or burned.A mole in center of chest was bleeding but was quickly stopped.Manufacturer response for adult multi-function electrodes pro-padz, pro-padz (per site reporter).Director of cardiology is reaching out to their representative.

Event Description

This is the second time an event has occurred with the pro-padz in use with a cardioversion patient.First patient also in pacu for cardioversion.After cardioversion and on removal of pads, there was noted to be a small burn on patient's chest along the edge of where pad was, approx 1.5 cm long, 1mm wide.Second event is being submitted now that we have set of pads, cardioversion was successful after one attempt.Removed anterior defib pad a burning smell was noted.Patient had red circular marks on her chest in shape of the pads as well.No skin appeared blistered or burned.A mole in center of chest was bleeding but was quickly stopped.Manufacturer response for adult multi-function electrodes pro-padz, pro-padz (per site reporter).Director of cardiology is reaching out to their representative.

• 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: 9705847
• MDR Text Key: 179241798
• Report Number: 9705847
• 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
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-4006
• Device Catalogue Number: 8900-4006
• Device Lot Number: 5119
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2020
• Date Report to Manufacturer: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28835 DA
• Patient Weight: 87