BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL DEFIBRILLATOR/MONITOR

    MDR report key: 20597586 · Received November 4, 2024

    Report

    Report Number
    3030677-2024-03914
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 15, 2024
    Report Date
    November 26, 2024
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000001
    PMA / PMN Number
    K021453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 HEARTSTART XL DEFIBRILLATOR INDICATING THAT THE CUSTOMER INQUIRED ABOUT PURCHASING INTERNAL PADDLES. BASED ON THE AVAILABLE INFORMATION, THE CUSTOMER DID NOT REPORT ANY MALFUNCTIONS OF THE DEVICE AND ONLY REQUESTED THE INTERNAL PADDLES AS A SPARE PART. THE RSE INFORMED THE CUSTOMER THAT THE INTERNAL PADDLES ARE AVAILABLE FOR PURCHASE. NO FURTHER EVALUATION IS WARRANTED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE CUSTOMER REQUESTED SPARE PARTS. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE CUSTOMER IS INQUIRING ABOUT PURCHASING REPLACEMENT INTERNAL PADDLES. NO OTHER INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773691 HEARTSTART XL DEFIBRILLATOR/MONITOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M4735A 00884838000001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown