BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2142391 · Received June 21, 2011

    Report

    Report Number
    1525712-2011-00278
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 20, 2011
    Manufacturer
    INVACARE
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL INTERVENTION SOUGHT DUE TO THE ALLEGED INCIDENT. TWO CNAS WERE PRESENT DURING A TRANSFER OF A RESIDENT FROM A BED. AS THEY STARTED TO LIFT THE RESIDENT USING (B)(4) LIFT, THEY PUT HER BACK ON THE BED TO REPOSITION HER. ALLEGEDLY, AT SOME POINT, DURING THE REPOSITIONING, ONE OF THE SLING STRAPS FOR SLING R113 BECAME DISLODGED FROM THE CRADLE. WHEN THEY LIFTED THE RESIDENT, THE SLING BECAME UNEVEN AND THE CRADLE SWUNG AND HIT THE MAST, CAUSING THE RESIDENT TO FALL TO THE FLOOR. THE RESIDENT ALLEGEDLY SUSTAINED A LACERATION TO THEIR HEAD. THE CNA'S LEVEL OF TRAINING AND DEVICE USAGE EXPERIENCE IS UNKNOWN.

    Description of Event or Problem · 1

    TWO CNAS WERE PRESENT DURING A TRANSFER OF A RESIDENT FROM A BED. AS THEY STARTED TO LIFT THE RESIDENT, THEY PUT HER BACK ON THE BED TO REPOSITION HER. AT SOME POINT, DURING THE REPOSITIONING, ONE OF THE SLING STRAPS ALLEGEDLY BECAME DISLODGED FROM THE CRADLE. WHEN THEY LIFTED THE RESIDENT, THE SLING BECAME UNEVEN AND THE CRADLE SWUNG AND HIT THE MAST, CAUSING THE RESIDENT TO FALL TO THE FLOOR. THE RESIDENT ALLEGEDLY SUSTAINED A LACERATION TO THEIR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FNG INVACARE RPL600-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R