BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH FL CEILING LIFT

    MDR report key: 13870298 · Received March 23, 2022

    Report

    Report Number
    3005753836-2022-00001
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    March 21, 2022
    Report Date
    September 20, 2023
    Manufacturer
    SAVARIA CONCORD LIFTS INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO CORRECT 5-DAY THAT WAS CHECKED IN ERROR ON THE INITIAL REPORT. INSTEAD, ONLY INITIAL BOX SHOULD HAVE BEEN CHECKED.

    Additional Manufacturer Narrative · 0

    THE LIFT AND CARRY BAR WERE INVESTIGATED. THE INVETIGATION DEMONSTRATED THE FOLLOWING: THE UNIT HAS BEEN REPEATEDLY MISUSED AND NOT PERIODICALLY INSPECTED. THE ORIGINAL DESIGN IS SUITABLE FOR ITS INTENDED USE; DRY ENVIRONMENT. THE ORIGINAL USER MANUAL HAS INSTRUCTIONS FOR INTENDED USE, CLEANING AND AGENTS ALLOWED, ENVIRONMENTAL CONDITIONS, PREVENTATIVE MAINTENANCE SCHEDULE THE ORIGINAL DESIGN, DESPITE SUBMITTED TO AGGRESSIVE ENVIRONMENTAL CONDITIONS REMAINED SAFE AND SUPPORTED LOAD FAR BEYOND THE MINIMUM SAFETY FACTORS FIELD SAMPLINGS (58 IN TOTAL FROM FEW SITES, ALL SAME AGE, ALL WET ENVIRONMENT) WERE INVESTIGATED. NO OBSERVATIONS OF SIMILAR CORROSION. MIN 400H SALT SPRAY TESTS + DURABILITY TESTS 20Y + ULTIMATE STRENGTH TESTS. ALL PASS ABOVE SAFETY FACTOR.

    Description of Event or Problem · 0

    DURING A TRANSFER FROM BEDROOM AND BATHROOM IN PATIENT'S HOME, THE CARRY BAR SEPARATED WHILE LIFTING THE PATIENT. PATIENT (FEMALE WITH CEREBRAL PALSY) WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION GIVEN THE FALL AND HER PREEXISTING CONDITION. THE DEALER SUSPECTED THAT THE SPREADER BAR IS BEING TAKEN IN THE SHOWER AND NEVER DISCONNECTED BASED ON SUBSTANTIAL SOAP RESIDUE/RUST AT CONNECTION POINT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    DURING A TRANSFER FROM BEDROOM AND BATHROOM IN PATIENT'S HOME, THE CARRY BAR SEPARATED WHILE LIFTING THE PATIENT. PATIENT (FEMALE WITH CEREBRAL PALSY) WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION GIVEN THE FALL AND HER PREEXISTING CONDITION. THE DEALER SUSPECTED THAT THE SPREADER BAR IS BEING TAKEN IN THE SHOWER AND NEVER DISCONNECTED BASED ON SUBSTANTIAL SOAP RESIDUE/RUST AT CONNECTION POINT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    DURING A TRANSFER FROM BEDROOM AND BATHROOM IN PATIENT'S HOME, THE CARRY BAR SEPARATED WHILE LIFTING THE PATIENT. PATIENT (FEMALE WITH CEREBRAL PALSY) WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION GIVEN FALL AND PREEXISTING CONDITION. THE DEALER SUSPECTED THAT THE SPREADER BAR IS BEING TAKEN IN THE SHOWER AND NEVER DISCONNECTED BASED ON THE SUBSTANTIAL SOAP RESIDUE/RUST AT CONNECTION POINT. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925247 MONARCH FL CEILING LIFT CEILING LIFT FSA SAVARIA CONCORD LIFTS INC. M929201 2019-07

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization