BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA DFM100

    MDR report key: 17993301 · Received October 23, 2023

    Report

    Report Number
    3030677-2023-04217
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    August 27, 2021
    Report Date
    July 23, 2024
    Manufacturer
    PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PCA WAS VISUALLY INSPECTED FOR SIGNS OF WEAR, DAMAGE, CORROSION, OR MISSING COMPONENTS, AND NO ANOMALIES WERE FOUND. THE PCA UNDER TEST WAS PLACED ON THE TEST FIXTURE, AND THE FIXTURE TURNED ON WITH THE THERAPY KNOB SET TO MONITOR. THE UNIT POWERED UP INDICATING THERAPY, POWER AND SOFTWARE ISSUES. THIS PCA WAS RETURNED "2.5V PROCESSOR SUPPLY OUT OF RANGE -". THIS WAS VERIFIED IN LAB TESTING, THE PCA FAILED THERAPY TESTS. AFTER REPAIR, THE DEVICE PASSED OPERATION CHECK AND GENERAL TESTING. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A MALFUNCTION OF THE PROCESSOR PCA. THE REPORTED PROBLEM WAS CONFIRMED. THE PROCESSOR PCA WAS DETERMINED TO BE DEFECTIVE. THE FSE REPLACED THE PROCESSOR PCA TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY THE FIELD SERVICE ENGINEER (FSE) AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE DFM100 DEVICE INDICATING THAT THE 2.5V PROCESSOR IS OUT OF RANGE. THE PCA (PRINTED CIRCUIT ASSEMBLY) WAS DELIVERED TO THE FUNCTIONAL ANALYSIS (FA) LAB FOR THE EVALUATION BY THE FAILURE ANALYSIS ENGINEER.THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. THE EFFICIA DFM100 DEFIBRILLATOR, MODEL# 866199, IS SUBSTANTIALLY SIMILAR TO THE HEARTSTART XL+ DEFIBRILLATOR (MODEL # 861290) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL # 861290.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE DFM100 DEVICE INDICATING THAT THE 2.5V PROCESSOR IS OUT OF RANGE. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. THE EFFICIA DFM100 DEFIBRILLATOR, MODEL# 866199, IS SUBSTANTIALLY SIMILAR TO THE HEARTSTART XL+ DEFIBRILLATOR (MODEL # 861290) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL # 861290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788468 EFFICIA DFM100 DEFIBRILLATOR MKJ PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. 866199

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown