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

Model Number 8900-4006

Device Problems Arcing at Paddles (1032); Device Emits Odor (1425); Noise, Audible (3273)

Patient Problems Abrasion (1689); Erythema (1840)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

The physician arrived to perform cardioversion on the patient.The physician placed the zoll defibrillator patches on the patient.Cardioversion was performed and was successful on the patient via zoll defibrillator, one shock at 200 joules.As patient was shocked, the rn, the physician, and crna all noted a loud "pop", the rn also witnessed a momentary red flash on the anterior pad at the same time as the popping sound.This was followed by a burning smell.The physician removed the anterior pad, reddened area was noted beneath the pad with slight abrasion appearance around small areas of pad boundaries.No blistering noted.Ice pack applied to the site.Biomed notified and they came and picked up the defibrillator and the patches and patch packaging.

Event Description

The physician arrived to perform cardioversion on the patient.The physician placed the zoll defibrillator patches on the patient.Cardioversion was performed and was successful on the patient via zoll defibrillator, one shock at 200 joules.As patient was shocked, the rn, the physician, and crna all noted a loud "pop", the rn also witnessed a momentary red flash on the anterior pad at the same time as the popping sound.This was followed by a burning smell.The physician removed the anterior pad, reddened area was noted beneath the pad with slight abrasion appearance around small areas of pad boundaries.No blistering noted.Ice pack applied to the site.Biomed notified and they came and picked up the defibrillator and the patches and patch packaging.

• Brand Name: PRO PADZ
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park dr; pawtucket RI 02861
• MDR Report Key: 13175527
• MDR Text Key: 283310228
• Report Number: 13175527
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00847946016661
• UDI-Public: (01)00847946016661
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8900-4006
• Device Lot Number: 4321B
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA
• Patient Sex: Male