MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS ADULT/CHILD RADIOLUCENT PADS; DEFIBRILLATOR

Model Number M3716A

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Skin Tears (2516)

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

Correction: this report has been updated from product problem to injury.H3 other text: the pads were disposed of by the customer.

Event Description

Correction: this report has been updated from product problem to injury.It was reported that defibrillation pads were pasted during the operation, the function was normal during the operation, and the patient's skin and epidermis were found broken at the pasting site after the operation.Additional details provided indicated the patient sustained empryosis (skin eruption of pustules) consistent with second degree burns and resulting blisters.The patient was successfully defibrillated, and the wound was sterilized and bandaged.The pads were used with a heartstart xl defibrillator.Cutaneous burns are a known, common risk of defibrillator procedures such as cardioversions but typically does not result in a life-threatening serious injury or permanent impairment.As such, this report has been updated from product problem to injury.A request was made for the pads to be retuned for investigation, but they have been disposed of by the customer and are not available, so failure analysis is not possible.Based on the information available, there is insufficient information to confirm the reported problem.The patient was treated for the alleged wound and released from the hospital per the information provided by the philips field service engineer.The investigation concludes that no further action is required at this time.

Event Description

Correction: this report has been updated to product problem.It was reported that defibrillation pads were pasted during the operation, the function was normal during the operation, and the patient's skin and epidermis were found broken at the pasting site after the operation.Additional details provided indicated the patient sustained empryosis (skin eruption of pustules) consistent with second degree burns and resulting blisters.The patient was successfully defibrillated, and the wound was sterilized and bandaged.The pads were used with a heartstart xl defibrillator.Cutaneous burns are a known, common risk of defibrillator procedures such as cardioversions but typically does not result in a life-threatening serious injury or permanent impairment.As such, this report has been updated to product problem.A request was made for the pads to be retuned for investigation, but they have been disposed of by the customer and are not available, so failure analysis is not possible.Based on the information available, there is insufficient information to confirm the reported problem.The patient was treated for the alleged wound and released from the hospital per the information provided by the philips field service engineer.The investigation concludes that no further action is required at this time.

Manufacturer Narrative

H3 other text : the pads were disposed of by the customer.

• Brand Name: HS ADULT/CHILD RADIOLUCENT PADS
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 18315425
• MDR Text Key: 330327425
• Report Number: 3030677-2023-04922
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: M3716A
• Device Catalogue Number: M3716A
• Device Lot Number: 122021-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male