BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-ZOEM EZ-TURN

    MDR report key: 1749176 · Received June 30, 2010

    Report

    Report Number
    2032121-2010-00001
    Event Type
    Injury
    Date Received
    June 30, 2010
    Date of Event
    February 1, 2008
    Report Date
    June 30, 2010
    Manufacturer
    KAP MEDICAL
    Product Code
    IKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALLEGED INCIDENT REPORTED BY A PATIENT'S ATTORNEY AS PART OF LEGAL CLAIM. LEGAL CLAIM RECEIVED ON 06/09/2010. DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR EVALUATION, AND NOT FURTHER INFORMATION WAS PROVIDED. FIRST REPORT OF THIS TYPE OF MALFUNCTION.

    Description of Event or Problem · 1

    THE INCIDENT REPORT STATED THE LATERAL TURNING SYSTEM INFLATED AND PUSHED PATIENT SIDEWAYS INTO THE HOSPITAL BED RAIL. THE LATERAL TURNING SYSTEM THEN CONTINUED TO INFLATE CAUSING THE PATIENT TO BE PUSHED FROM THE BED AND ONTO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-ZOEM EZ-TURN IKZ 890.5225 IKZ KAP MEDICAL K-ZOEMSCMS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| S UNSPECIFIED HOSPITAL BED WITH RAISED SIDE RAILS