BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAPID RESPONSE HUT TABLE

    MDR report key: 2108204 · Received May 16, 2011

    Report

    Report Number
    1932056-2011-00004
    Event Type
    Other
    Date Received
    May 16, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Removal / Correction Number
    Z-1973/1975-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS SCHEDULED TO BE EVALUATED BY MPI ONCE IT IS RETURNED FROM THE CUSTOMER. A F/U REPORT WILL BE FILED ONCE EVAL IS COMPLETED DETAILING THE METHODS, RESULTS, AND CONCLUSIONS OF THE EVAL. THIS DEVICE WAS SUBJECT TO A FIELD CORRECTION ACTION FOR A SIMILAR PROBLEM ((B)(4)). MPI HAS OPENED A CAPA ((B)(4)) ON THE EFFECTIVENESS OF THE FIELD ACTION WHERE THE INVESTIGATION SHOWS THAT THE PROBLEM WITH THIS TABLE IS SITE SPECIFIC AND NOT SYSTEMIC TO THE OTHER TABLES INVOLVED IN THE FIELD ACTION. THIS WILL BE TESTED AND CONFIRMED ONCE THE COMPANY RECEIVES THE DEVICE FROM THE FACILITY.

    Description of Event or Problem · 1

    DURING A (B)(4) STUDY THE PT'S HEAD WAS ELEVATED IN A STEEP REVERSE TRENDELENBURG POSITION WHEN THE PT'S HEART RATE FELL TO 30 BPM. THE STAFF ATTEMPTED TO MOVE THE TABLE TO A LEVEL POSITION USING THE ELECTRIC CONTROLS AND THE TABLE WAS UNRESPONSIVE. THE STAFF MANUALLY REMOVED THE PT FROM THE TABLE AND PLACED THE PT FLAT ON THE FLOOR. AT THAT TIME THE HEART RATE RECOVERED WITHOUT ANY CPR OR OTHER MED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID RESPONSE HUT TABLE HEAD-UP TILT TABLE LGX MEDICAL POSITIONING, INC. 1017

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other