BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M2736A AVALON U/S TRANSDUCER

    MDR report key: 9301458 · Received November 8, 2019

    Report

    Report Number
    3007409280-2019-00080
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Report Date
    October 15, 2019
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS RETURNED. DEVICE EVALUATION IDENTIFIED THAT THE ULTRASOUND TRANSDUCER ELECTRICAL CHECK FAILED CONFIRMING THE REPORTED EVENT. THERE WERE THREE LOOSE 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, INCOMING VISUAL INSPECTION FOUND THAT THE KNOB WAS MISSING. 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 A ISSUE WITH THE CRYSTALS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091488 PHILIPS M2736A AVALON U/S TRANSDUCER TRANSDUCER HGM PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FFPH5505

    Patients

    Seq Age Sex Outcome Treatment
    1