BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPIC VAC-PAC

    MDR report key: 981815 · Received January 17, 2008

    Report

    Report Number
    3018859-2008-00003
    Event Type
    Other
    Date Received
    January 17, 2008
    Date of Event
    December 11, 2007
    Report Date
    January 17, 2008
    Manufacturer
    OLYMPIC MEDICAL, A DIVISION OF NATUS MEDICAL
    Product Code
    CCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE VAC-PAC WAS RETURNED TO OLYMPIC MEDICAL FOR INVESTIGATION. A VISUAL EVALUATION DETERMINED THAT THE SKIN OF THE VAC-PAC HAD BEEN COMPROMISED BY A SHARP OBJECT (CONSITENT WITH A TOWEL CLIP). NOTE THAT THE VAC-PAC INSTRUCTION MANUAL INCLUDES THE FOLLOWING CAUTIONS UNDER "GENERAL USE": THIS PRODUCT IS FOR USE AS A POSITIONING AID ONLY; DO NOT USE AS AN IMMOBILIZER OR RESTRAINT. AVOID PUNCTURING THE VAC-PAC WITH TOWEL CLIPS OR OTHER SHARP INSTRUMENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THAT THE OLYMPIC VAC-PAC (A SURGICAL POSITIONING DEVICE) SOFTENED, WHILE BEING USED ON A PT DURING SURGERY. THE DEVICE'S PLUG WAS IN PLACE AT THE TIME THAT IT SUDDENLY SOFTENED (SEVERAL HOURS INTO THE SURGERY). PT FELL FROM OPERATING TABLE AND WAS KEPT OVERNIGHT IN ICU FOR EVALUATION. PT SUSTAINED SOME BRUISING BUT NO OTHER APPARENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPIC VAC-PAC SURGICAL POSITIONER (CCX) CCX OLYMPIC MEDICAL, A DIVISION OF NATUS MEDICAL SIZE #32 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization