BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOSPITAL BED ELECTRIC

    MDR report key: 620419 · Received July 7, 2005

    Report

    Report Number
    2182305-2005-00012
    Event Type
    Other
    Date Received
    July 7, 2005
    Date of Event
    November 11, 2003
    Report Date
    July 1, 2005
    Manufacturer
    OPTIMA HEALTHCARE, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DISTRIBUTOR BY DEALER WITH REGARD TO A LAWSUIT THAT HAS BEEN FILED. PLAINTIFF ALLEGES THAT THEY WERE INJURED WHEN THEIR HOSPITAL BED COLLAPSED. THIS HOSPITAL BED WAS DISTRIBUTOR BY SUNRISE MEDICAL AND SOLD TO DEALER AND THEN SOLD TO THE END USER. THE DEALER STATED THE BED WAS DELIVERED IN 2003. 10 DAYS LATER, THEIR OFFICE WAS NOTIFIED THAT THE BED ALLEGEDLY COLLAPSED WHILE THE CLAIMANT WAS IN IT. DEALER SENT A TECHNICIAN OUT THE NEXT DAY TO PICK UP THE BED AND EXCHANGE IT WITH ANOTHER BED. THE TECHNICIAN NOTED THAT THE PIN CAME OUT OF THE BED WHICH CAUSED THE HEAD END TO COLLAPSE. NOTHING WAS MENTIONED ABOUT INJURIES UNTIL THEY RECEIVED SERVICE OF THIS LAWSUIT. THEY (THE DEALER) HAVE SINCE PUT THE BED BACK IN SERVICE AND HAS HAD NO FURTHER ISSUE. THE DEALER DOESN'T KNOW IF IT WAS AN INSTALLATION ISSUE WHEN IT WAS PUT TOGETHER OR IF THE CALIMANT DID SOMETHING TO MAKE THE PIN DISLODGE. THE DISTRIBUTOR DID NA INVESTIGATION INTO POSSIBLE SITUATIONS THAT COULD CAUSE THE PIN TO COME OUT OF THE BACK SECTION ALLOWING THE BACK SECTION TO FALL. CO FOUND THAT IF THE DRIVE TUBE IS CONNECTED PER THE USER MANUAL INSTRUCTIONS THE BACK SECTION WILL OPERATED PROPERLY WITH NO INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL BED ELECTRIC BED ELECTRIC FNL OPTIMA HEALTHCARE, INC. IC-5410 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other