BEUDAMED
    FDA Adverse Event Death Summary report: N

    S3 PX4-3005

    MDR report key: 18916532 · Received March 15, 2024

    Report

    Report Number
    0001831750-2024-00328
    Event Type
    Death
    Date Received
    March 15, 2024
    Date of Event
    December 15, 2023
    Report Date
    March 15, 2024
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    UDI-DI
    07613327278422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS EVALUATED BY A STRYKER FIELD SERVICE TECHNICIAN. HE TESTED ALL THREE ZONES OF THE BED EXIT WITH THE NURSE PRESENT AND WAS UNABLE TO DUPLICATE THE ISSUE. BASED ON THIS INFORMATION, IT WAS DETERMINED THAT THE BED EXIT ALARM NOT SOUNDING WAS MOST LIKELY DUE TO IT NOT BEING SET CORRECTLY, NOT ANY COMPONENT LEVEL DEFECT OR MALFUNCTION. AFTER FURTHER COMMUNICATION WITH THE USER FACILITY, IT WAS NOT CERTAIN THAT THE BED EXIT ALARM HAD BEEN TURNED ON. A STRYKER QUALITY ASSURANCE ENGINEER SPOKE WITH A NURSE AT THE ACCOUNT WHO EXPLAINED THAT THE PATIENT DIED AT THE TIME OF THE FALL. IT IS UNKNOWN IF THE PATIENT¿S DEATH WAS A RESULT OF THE FALL OR A MEDICAL EVENT. THE ISSUE WAS RESOLVED BY CONFIRMING NO FURTHER ACTION WAS NEEDED BY STRYKER AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE'S BED ALARM DID NOT SOUND. AS A RESULT, A PATIENT FELL OUT OF BED. THE PATIENT PASSED AWAY. IT IS UNKNOWN IF THIS WAS A RESULT OF THE FALL OR A SEPARATE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755020 S3 PX4-3005 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO 07613327278422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death