MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SWITCHED INTERNAL PADDLES -4.5 CM; DEFIBRILLATOR

Model Number	M4743A
Medical Device Problem Codes	Failure to Discharge (1169); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Tachycardia (2095); Ventricular Fibrillation (2130)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the rhythm of a heart surgery patient changed to ventricular tachycardia/ventricular fibrillation after detachment from the perfusion machine.An attempt was made to change the patient's rhythm using a defibrillator with electrode paddles placed on the surface of the heart.However, the device did not deliver a shock, and the patient was briefly reconnected to the perfusion machine.The defibrillator had been successfully checked in the morning as per normal practice.There is suspicion that the defibrillator paddles did not function.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Updated summary and code grids.
Event or Problem Description
This report is based on information provided by philips¿ service representative and has been investigated by the philips complaint handling team.Philips received a possible complaint on the heartstart intrepid since the customer indicated the internal paddles did not work.There is suspicion that the defibrillator paddles did not function.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.The customer replaced the paddles and the device returned to normal operation.A good faith effort was made to obtain additional information regarding customer resolution and patient involvement associated with this complaint, but attempts have been unsuccessful.Based on the information available the reported paddles problem was confirmed only by the customer the paddles were replaced, and the device returned to normal operation per customer.If additional information is later obtained, the complaint will be reopened.

• Brand Name: SWITCHED INTERNAL PADDLES -4.5 CM
• Common Device Name: 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: 18246668
• Report Number: 3030677-2023-04742
• Device Sequence Number: 6644933
• Product Code: MKJ
• UDI-Device Identifier: 00884838003347
• UDI-Public: 00884838003347
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K021453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• 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
• Operator of Device: Health Professional
• Device Model Number: M4743A
• Device Catalogue Number: M4743A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown