BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER CALIBRE

    MDR report key: 7946236 · Received October 9, 2018

    Report

    Report Number
    3010605276-2018-00009
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    June 9, 2018
    Report Date
    October 5, 2018
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT# 2018006 WERE ENTERED INTO OUR SYSTEM. THE LIFT HAS NOT YET RETURNED AS OF THIS WRITING.

    Description of Event or Problem · 0

    WE RECEIVED THIS MDR EVENT FROM OUR USA CUSTOMER AND IT STATED AS BELOW: IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "THE PATIENT FELL WHILE TWO CNAWERE USING THELLIFT TO GO TAKE THE PATIENT A BATH." UPON SPEAKING TO THE FACILITY, THEY STATED THAT THE SLING RIPPED WITH THE RESIDENT IN IT AND HE FELL. THE FACILITY THREW THE SLING IN THE TRASH AND DOES NOT KNOW THE MODEL NUMBER OR MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786855 HOYER CALIBRE ELECTRIC PATIENT LIFT, FSA APEX HEALTH CARE MFG., INC. HOY-CALIBRE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR