BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M2735A SMART TOCO + TRANSDUCER

    MDR report key: 9212594 · Received October 20, 2019

    Report

    Report Number
    3007409280-2019-00047
    Event Type
    Malfunction
    Date Received
    October 20, 2019
    Date of Event
    September 23, 2019
    Report Date
    September 23, 2019
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS RETURNED. DEVICE EVALUATION IDENTIFIED AN INTERNAL SHORT AND BROKEN SCREW POSTS. THE US SMART TRANSDUCER BELT KNOB, ECG CONNECTOR, ECG FLEX CIRCUIT, CASE COVER RUBBER GASKET, BOTTOM COVER, AND THE PLUS TOP COVER WERE REPLACED. THE PARAMETER TESTS WERE PERFORMED AND ALL PASSED. A DEFINITIVE ROOT CAUSE FOR THE CASE AND CABLE ISSUES CANNOT 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR THE DEVICE WAS HAVING CASE AND CABLE ISSUES. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT HARM. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006406 PHILIPS M2735A SMART TOCO + TRANSDUCER TRANSDUCER HGM PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1