BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 18323745 · Received December 13, 2023

    Report

    Report Number
    3030677-2023-04944
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 17, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    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

    CORRECTION: THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS AUTHORIZED SERVICE PERSONNEL (ASP) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. THE PADS (LOT 111622-04) WERE RETURNED TO PHILIPS FOR ADDITIONAL ANALYSIS. THE COMPLAINT WAS ESCALATED FOR TECHNICAL COMPLAINT INVESTIGATION AND THE RESULTS INDICATE THAT A BROWN SPOT OF UNKNOWN ORIGIN HAD PENETRATED THROUGH THE LINER FROM THE NON-LAMINATED SIDE TO THE LAMINATED SURFACE. PADS WERE TESTED AND IT WAS CONFIRMED THAT THE PADS FUNCTIONED AS EXPECTED PER DESIGN. OPERATIONAL CHECK WAS SUCCESSFULLY RUN USING THE PADS. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THERE WAS NO FAULT FOUND WITH THESE PADS. THE ROOT CAUSE OF THE BROWN SPOT WAS NOT CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE CUSTOMER USED SPARE PADS AT THE TIME OF THE EVENT, TO RESOLVE THEIR ISSUE. THE DEVICE HAS REMAINED IN SERVICE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS AUTHORIZED SERVICE PERSONNEL (ASP) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. THE INSPECTORS DETERMINED THAT THIS WAS A MALFUNCTION OF THE PAD WHICH WAS REPLACED. 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 THE PAD. THE REPORTED PROBLEM WAS CONFIRMED. THE CUSTOMER REPLACED THE PAD TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, WHEN THE CUSTOMER TRIED TO USE IT, THE PAD PART SEEMED TO BE UNUSUAL. THE PAD APPEARED TO BE BURNT. SO THE CUSTOMER STOPPED USING IT. THE DEVICE WAS REPORTED TO BE IN USE, HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART XL INDICATING THAT THE PAD APPEARS TO BE BURNT. THE USER FOUND THE PAD TO BE DEFECTIVE BEFORE USING IT ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824644 HEART START XL DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown