BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS M2734B SMART TOCO TRANSDUCER

    MDR report key: 12042925 · Received June 22, 2021

    Report

    Report Number
    3007409280-2021-00006
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    May 27, 2021
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    HGM
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE STATES: "THE PATIENT STATED SHE WAS FEELING TINY "SHOCKS" WHERE THE TOCO TOUCHED HER SKIN". THIS DEVICE IS AFFECTED BY RECALL2019-01. THERE WAS NO PATIENT HARM. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE TECHNICIAN TESTED THE DEVICE ON HIMSELF AND CONFIRMED THAT THE DEVICE WAS NOT SHOCKING HIM; RATHER, THE SERIAL NUMBER STICKER WAS POKING HIM. THE CABLE WAS REPLACED FOR PREVENTATIVE MAINTENANCE. A GAIN MEASUREMENT TEST AND A PARAMETER TEST WERE PERFORMED AND ALL TESTS PASSED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE THAT THE TECHNICIAN DID NOT PROPERLY ATTACH THE SERIAL NUMBER STICKER TO THE BACK OF THE DEVICE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    THE PATIENT STATED SHE WAS FEELING TINY "SHOCKS" WHERE THE TOCO TOUCHED HER SKIN. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943678 PHILIPS M2734B SMART TOCO TRANSDUCER TRANSDUCER HGM PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH FIMF3505-B

    Patients

    Seq Age Sex Outcome Treatment
    1