BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD304 MATERNITY BED

    MDR report key: 2760668 · Received September 19, 2012

    Report

    Report Number
    1831750-2012-09953
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    August 22, 2012
    Report Date
    August 22, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), FOWLER GUIDE WELDMENT, BALLSCREW ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER WAS STUCK AND NOT ABLE TO LOWER IT ELECTRONICALLY AND MANUALLY. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LD304 MATERNITY BED LABOR AND DELIVERY BED HDD STRYKER MEDICAL 4701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1