BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-MAX II SHOULDER EXPOSURE POSITIONER

    MDR report key: 5008122 · Received August 17, 2015

    Report

    Report Number
    1643264-2015-00115
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Date of Event
    February 9, 2015
    Report Date
    February 10, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW WILL CONTINUE TO MONITOR FOR ANY FUTURE OCCURRENCES OF THIS FAILURE TYPE. NO FURTHER ACTION IS DEEMED NECESSARY AS A RESULT. (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE STAFF PREPARED THE T-MAX ONTO THE OPERATING ROOM TABLE; IT WAS REQUESTED THAT THE SURGEON CHECK IT FOR POSITIONING AND ATTACHMENT. SURGEON APPROVED. (B)(6) YEAR OLD PATIENT, LIGHTLY SEDATED, WAS POSITIONED ONTO THE T-MAX WHEN IT DISENGAGED FROM THE OPERATING ROOM TABLE. STAFF ABLE TO CATCH PATIENT. (NO KNOWN INJURIES AT THIS TIME.) STAFF RE-ADJUSTED T-MAX AND POSITIONED PATIENT ONTO IT. SURGEON PROCEEDED WITH THE PROCEDURE WITH NO FURTHER INCIDENT. S&N SALES REP NOR S&N WERE INFORMED OF THIS INCIDENT BY THE HOSPITAL. SALES REP HEARD ABOUT THE INCIDENT "IN PASSING" WHILE AT THE HOSPITAL ON (B)(6) 2014. HE IMMEDIATELY SCHEDULED TIME FOR RE-IN SERVICING THE STAFF ON THE T-MAX THAT EVENING. NOTHING IS BEING RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543579 T-MAX II SHOULDER EXPOSURE POSITIONER ACCESSORIES, OPERATING-ROOM, TABLE FWZ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR