BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT SELECT BED

    MDR report key: 2447549 · Received February 6, 2012

    Report

    Report Number
    2447549
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 6, 2012
    Manufacturer
    CARROLL HOSPITAL GROUP
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING LOWERED IN SPIRIT SELECT BED WHEN A LARGE FLASH, POPPING SOUND AND BURN SMELL WAS NOTED. THE WALL PLUG WAS IMMEDIATELY DISCONNECTED AND PATIENT WAS MOVED TO ANOTHER BED. ON INSPECTION OF THE BED, A SLIT WAS FOUND IN THE ELECTRICAL CORD AND DURING THE LOWERING PROCESS, IT CAME IN CONTACT WITH A GROUND. KINETICS CONCEPT INCORPORATED (KCI) WAS CONTACTED AND QUICKLY RESPONDED. IT WAS FOUND THAT THE HEADBOARD TO THE BED HAD BEEN REMOVED FROM THE BED WHICH ALLOWED THE ELECTRICAL CORD TO BE WRAPPED AROUND THE FRAME. IT BECAME PINCHED IN THE BED MECHANISM WHEN IT WAS LOWERED CAUSING THE CORD TO BECOME COMPROMISED. NO PATIENT INJURY.======================MANUFACTURER RESPONSE FOR SPIRIT SELECT BED, SPIRIT SELECT BED (PER SITE REPORTER).======================KCI IS INVESTIGATING THE BED AND WILL UPDATE US ON THEIR FINDINGS. THEY ALSO REMOVED ONE ADDITIONAL BED FROM THE FACILITY WITH A POSSIBLE COMPROMISED ELECTRICAL CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIRIT SELECT BED SPIRIT SELECT BED IKZ CARROLL HOSPITAL GROUP SPIRIT SELECT BED *

    Patients

    Seq Age Sex Outcome Treatment
    1 *