BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M1356A US BELT/WIRE KNOB

    MDR report key: 9305833 · Received November 11, 2019

    Report

    Report Number
    3007409280-2019-00083
    Event Type
    Malfunction
    Date Received
    November 11, 2019
    Report Date
    October 17, 2019
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS RETURNED. DEVICE EVALUATION IDENTIFIED THAT THE ULTRASOUND TRANSDUCER ELECTRICAL CHECK AND THE SAFETY, MAINTENANCE AND CALIBRATION TESTING FAILED CONFIRMING THE REPORTED EVENT. THE DEVICE HAD LOOSE CRYSTALS. THE PIEZOELECTRIC CRYSTALS WERE TIGHTENED. THE PARAMETER TESTS WERE PERFORMED AND ALL PASSED. A DEFINITIVE ROOT CAUSE FOR THE LOW SOUNDING CRYSTALS COULD NOT BE DETERMINED. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED. SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL REVIEW OF THE HHE-2019-01 AND HHE-2019-02 ASSESSMENTS HAVE BEEN CONDUCTED. THE HEALTH CARE PROFESSIONAL HAS CONCLUDED ALL FETAL TRANSDUCER PRODUCTS IN RELATION TO THE RESULTED RECALL FOR BOTH HHE'S PROVIDED, DO NOT QUALIFY AS REPORTABLE INCIDENCES; THEREFORE, THIS MALFUNCTION SHOULD NOT HAVE BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE; HOWEVER, LOOSE PARTS WERE HEARD INSIDE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE CUSTOMER REPORTED THE CRYSTALS WERE LOOSE AND THE DEVICE WAS NOT PICKING UP A SIGNAL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098981 PHILIPS M1356A US BELT/WIRE KNOB TRANSDUCER HGM PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FFPH5505

    Patients

    Seq Age Sex Outcome Treatment
    1