BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002 SECURE II

    MDR report key: 2191874 · Received July 29, 2011

    Report

    Report Number
    1831750-2011-07823
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: DISCONNECTED BED-LOCK MODULE CABLE, DAMAGED MOTION INTERRUPT PAN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SVC REPORT THAT THE SIDERAILS WERE NOT FUNCTIONING, DUE TO A DISCONNECTED BED-LOCK MODULE CABLE; THE MOTION INTERRUPT PAN WAS CRACKED AT THE BOLT ATTACHMENT, AND IT WAS HANGING FROM ONE END UNDERNEATH THE BED. IT IS UNKNOWN IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3002 SECURE II A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1