MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problems Electrical /Electronic Property Problem (1198); Defibrillation/Stimulation Problem (1573)

Patient Problem Burn(s) (1757)

Event Date 12/04/2023

Event Type  malfunction  

Event Description

It was reported that the customer had an incident when using a heartstart xl on a patient.The patient suffered burns.Additional details have been requested.

Event Description

This report is based on information provided by philips remote service engineer (rse) and with an investigation documented by philips complaint handling.Philips received a complaint on the heartstart xl defibrillator indicating that patient suffered with burns during device use.The affected area was reported as red and dry and the size of the 2 defibrillation pads.The affected area was treated with a cream.It is expected that the reported injury will heal completely.Based on the available information, the report of burns is determined to be minor injury, which does not meet the criteria for a serious injury.

Manufacturer Narrative

The product malfunction was unable to be confirmed because multiple gfe requests for additional information were unsuccessful.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.Multiple gfe requests for additional information were unsuccessful.

• Brand Name: HEART START XL
• 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: 18341618
• MDR Text Key: 330663253
• Report Number: 3030677-2023-04995
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021453
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Device Catalogue Number: M4735A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/16/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2024
• 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 Outcome(s): Life Threatening