BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS OR BED

    MDR report key: 1743024 · Received June 25, 2010

    Report

    Report Number
    MW5016540
    Event Type
    Other
    Date Received
    June 25, 2010
    Date of Event
    April 1, 2010
    Report Date
    June 25, 2010
    Manufacturer
    STERIS CORP.
    Product Code
    FQO
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN TRENDELENBURG DURING AN EXPLORATORY LAPAROTOMY. AT THE END OF THE CASE, WHEN ANESTHESIA WAS LEVELING THE BED, THE ORANGE CORD FROM THE SCD MACHINE WAS CAUGHT UNDER THE SKIRT OF THE BED, CAUSING THE CONTROLS TO MALFUNCTION. THE FOOT OF THE BED WENT UP IN A 90 DEGREE ANGLE, AS DID THE PT'S LEGS UNTIL THE SAFETY STRAP COULD BE LOOSENED FROM THE THIGHS. DR EXAMINED THE PT AND SHE WAS MOVING HER LEGS WITHOUT DIFFICULTY, AS SHE WAS COMING OUT OF ANESTHESIA. PT WAS TAKEN TO PACU AND OBSERVED FOR FURTHER INJURY. REPORTED INCIDENT TO STERIS ON 4/5/2010, AND RECEIVED CALL FROM THEIR QUALITY MANAGEMENT TEAM. ON 4/8/10, STERIS COMPANY REP WAS HERE TO INSPECT TABLE. ALL REPAIRS COMPLETED BY STERIS CORP TECHNICIAN ON 4/15/2010. OPERATING ROOM TABLE HAD BEEN PULLED FROM SERVICE UNTIL INSPECTION AND REPAIRS COULD BE COMPLETED. ON (B)(6) 2010, AFTER INCIDENT - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SURGERY BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS OR BED OR TABLE FQO STERIS CORP. 3085 5P

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR