BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLIBRIUM PE SUPPORT SURFACE

    MDR report key: 18676932 · Received February 9, 2024

    Report

    Report Number
    0001831750-2024-00306
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 11, 2024
    Report Date
    June 26, 2024
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKZ
    UDI-DI
    07613327523867
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT RECEIVED MARKS ON THEIR BACK WHILE LAYING ON THE INTEGRATED MATTRESS. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THE NEED FOR TREATMENT. THE ORIGINAL PRODUCT WAS INCORRECTLY REPORTED. THE CORRECT PRODUCT IDENTIFICATION HAS BEEN CORRECTED IN SECTION D4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT RECEIVED ALLEGED SKIN ISSUES WHILE LAYING ON THE INTEGRATED MATTRESS. FURTHER INFORMATION HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT RECEIVED MARKS ON THEIR BACK WHILE LAYING ON THE INTEGRATED MATTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577857 ISOLIBRIUM PE SUPPORT SURFACE BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO 07613327523867
    68517 ISOLIBRIUM PE SUPPORT SURFACE BED, PATIENT ROTATION, POWERED IKZ STRYKER MEDICAL-KALAMAZOO 07613327523867

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other