BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SPIRIT SELECT

    MDR report key: 9639329 · Received January 28, 2020

    Report

    Report Number
    3006433555-2020-00003
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 1, 2020
    Report Date
    January 29, 2020
    Manufacturer
    STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS
    Product Code
    FNL
    UDI-DI
    07613327284546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B5 HAS BEEN UPDATED TO INCLUDE A DESCRIPTION OF THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE SIDERAIL HAD A FALSE LATCH. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED; THERE WAS A BROKEN/DAMAGED COMPONENT. THE DEVICE WAS REPAIRED AND RETURNED. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED . THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102965 SPIRIT SELECT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS 5700 07613327284546

    Patients

    Seq Age Sex Outcome Treatment
    1