MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTERNAL PEDIATRIC PADDLE SET; DEFIBRILLATOR

Model Number	M4735A
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Unspecified Heart Problem (4454)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a ventricular rhythm problem of the patient at the end of the intervention, they needed to use the defibrillation paddles.At the moment of the shock, the defibrillator turned off and the shock was not administered.The paddles seem to have created an electrical short-circuit.
Additional Manufacturer Narrative
Updated summary, catalog item identifier and code grids.
Event or Problem Description
This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the als device indicating that shock was not delivered.During a ventricular rhythm problem of the patient at the end of the intervention, they needed to use the defibrillation paddles.At the moment of the shock, the defibrillator turned off and the shock was not administered.The paddles seem to have created an electrical short-circuit.The device stopped and restarted.The customer was advised to replace the paddles.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of paddles.The reported problem was confirmed.The customer was informed that the paddles needed to be replaced, however, we are unable to confirm additional details as the customer did not respond to requests for additional information.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTERNAL PEDIATRIC PADDLE SET
• 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: 18158924
• Report Number: 3030677-2023-04562
• Device Sequence Number: 7999522
• Product Code: MKJ
• UDI-Device Identifier: 00884838002104
• UDI-Public: 00884838002104
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: M4735A
• Device Catalogue Number: M4735A
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 11/27/2023
• 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