BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 8620680 · Received May 17, 2019

    Report

    Report Number
    1218950-2019-03555
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    November 3, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT ORIGINALLY SUBMITTED WITH CFN# (B)(4); THE CORRECT CFN# IS (B)(4).

    Additional Manufacturer Narrative · 0

    REPORT ORIGINALLY SUBMITTED WITH CFN# 1218950; THE CORRECT CFN# IS 3030677.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WON'T POWER ON. THIS DEVICE HAD BEEN SHORTED SOMEHOW AND MELTED THE CASE. A PHILIPS REPAIR BENCH TECHNICIAN EVALUATED THE DEVICE AND CONFIRMED THE ISSUE. THE DAMAGE WAS SO EXTENSIVE THAT THE TECHNICIAN WAS NOT ABLE TO DETERMINE THE INITIAL CAUSE OF THE FAILURE. MULTIPLE PARTS WERE BURNED AND REQUIRED REPLACEMENT. THE REPAIR BENCH TECHNICIAN REPLACED MULTIPLE PARTS INCLUDING: HIF PCA, PRINTER PCA, INVERTER PCA, POWER SUPPLY ASSEMBLY, PRINTER ASSEMBLY, DISPLAY ASSEMBLY, FRONT CASE, REAR CASE, ECG MODULE, THERAPY CAP TRAY, FAN ASSEMBLY, PRINTER CABLE, PROCESSOR TO THERAPY CABLE, HIF CABLE, INVERTER CABLE, BATTERY POWER CABLE, BATTERY DATA CABLE, DISPLAY CABLE, 50 OHM RESISTOR, INTERNAL RESISTOR, INSULATOR, STAND OFFS, NAME PLATE, SILICONE GASKET, REAR I/O, LAN CABLE, POWER SUPPLY CABLE, SPEAKER ASSEMBLY, BATTERY PCA, THERAPY PCA, DEFIB CAP, LABEL SET, THERAPY PORT, PROCESSOR PCA. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. AS MULTIPLE COMPONENTS WERE INSTALLED IN THE PROCESS OF REPAIRING THE DEVICE, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WON'T POWER ON. THIS DEVICE HAD BEEN SHORTED SOMEHOW AND MELTED THE CASE. A PHILIPS REPAIR BENCH TECHNICIAN EVALUATED THE DEVICE AND CONFIRMED THE ISSUE. THE DAMAGE WAS SO EXTENSIVE THAT THE TECHNICIAN WAS NOT ABLE TO DETERMINE THE INITIAL CAUSE OF THE FAILURE. MULTIPLE PARTS WERE BURNED AND REQUIRED REPLACEMENT. THE REPAIR BENCH TECHNICIAN REPLACED MULTIPLE PARTS INCLUDING: HIF PCA, PRINTER PCA, INVERTER PCA, POWER SUPPLY ASSEMBLY, PRINTER ASSEMBLY, DISPLAY ASSEMBLY, FRONT CASE, REAR CASE, ECG MODULE, THERAPY CAP TRAY, FAN ASSEMBLY, PRINTER CABLE, PROCESSOR TO THERAPY CABLE, HIF CABLE, INVERTER CABLE, BATTERY POWER CABLE, BATTERY DATA CABLE, DISPLAY CABLE, 50 OHM RESISTOR, INTERNAL RESISTOR, INSULATOR, STAND OFFS, NAME PLATE, SILICONE GASKET, REAR I/O, LAN CABLE, POWER SUPPLY CABLE, SPEAKER ASSEMBLY, BATTERY PCA, THERAPY PCA, DEFIB CAP, LABEL SET, THERAPY PORT, PROCESSOR PCA. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. AS MULTIPLE COMPONENTS WERE INSTALLED IN THE PROCESS OF REPAIRING THE DEVICE, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WON'T POWER ON. THERE WAS NO REPORTED PATIENT OR USER INVOLVEMENT AND NO ADVERSE PATIENT/USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415423 HEARTSTART XL+ DEFIBRILLATOR/MONITOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1