BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL SCALE

    MDR report key: 7192662 · Received January 15, 2018

    Report

    Report Number
    1317256-2017-00001
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    November 20, 2017
    Report Date
    January 12, 2018
    Manufacturer
    SR INSTRUMENTS INC
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION IS COPIED FROM THE 30 DAY REPORT RECEIVED FROM JOERNS: ADDITIONAL SUSPECT MEDICAL DEVICE: BRAND NAME: HOYER HPL700. MODEL# & CATALOG#: HPL700. SERIAL#: (B)(4). MANUFACTURER: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES. OPERATOR OF DEVICE: HEALTH PROFESSIONAL. AS OF 1/14/2018 NO ADDITIONAL INFORMATION FROM JOERNS HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    WAS NOTIFIED FROM JOERNS (B)(4) 2017 THAT A PRODUCT PROBLEM HAD OCCURRED CONTENT COPIED BELOW: "IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "THE CRADLE (KING PIN) UN-SCREWED AND DROPPED THE PATIENT AND CRADLE." UPON SPEAKING TO THE FACILITY, THEY STATED THAT "THE PATIENT WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR. THE SCREWS ON THE BOTTOM OF THE SCALE CAME UN-DONE. THE RESIDENT DID NOT FALL, BUT WAS LOWERED BACK ONTO THE BED." COMPLAINT# (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE LIFT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS WRITING, THE LIFT HAS NOT BEEN RETURNED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35834 UNIVERSAL SCALE PATIENT LIFT SCALE FSA SR INSTRUMENTS INC HOY-SCALE-LP

    Patients

    Seq Age Sex Outcome Treatment
    1