BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1051786-2019-00015

    MDR report key: 8499738 · Received April 10, 2019

    Report

    Report Number
    1051786-2019-00015
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Report Date
    April 2, 2019
    PMA / PMN Number
    K090785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A CASTER BECOME DETACHED FROM THE MONITOR CART. THERE WAS NO REPORTED PATIENT IMPACT.

    Patients

    Seq Age Sex Outcome Treatment
    1