BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY 440

    MDR report key: 1171336 · Received September 17, 2008

    Report

    Report Number
    9681684-2008-00026
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASSETTE WAS RETURNED TO BHM FOR EVALUATION. THE LIFT HAD BEEN NEGLECTED AND ABUSED IN A MANNER THAT RESULTED IN ITS CONDITION. THE STRAP OF THE LIFT WAS OBVIOUSLY GREATLY GRAYED. THE OPERATING AND PREVENTIVE MAINTENANCE INSTRUCTIONS (OPI) INDICATE THE STRAP SHOULD HAVE BEEN CHECKED AT LEAST ON A DAILY BASIS, AND THE LIFT TAKEN OUT OF SERVICE AND THE STRAP CHANGED BEFORE BEING USED AGAIN. THE PREVIOUSLY SUSTAINED DAMAGE ON THE CASING SHOULD HAVE ALSO PREVENTED THE USE OF THE LIFT AS SPECIFIED IN THE OPI. OVERALL, THE LIFT WAS IN PITIFUL SHAPE WHEN IT ARRIVED AT BHM. ACCORDING TO (B) (4) RECORDED SERVICE CALLS, ONLY ONE MAXI SKY 440 AT THAT FACILITY HAD HAD THE STRAP CHANGED, AND IT WAS NOT THE ONE INVOLVED IN THIS INCIDENT. THE LIFT HAS PERFORMED 7250 CYCLES. IF THE STRAP HAD NOT BEEN CHANGED SINCE INSTALLATION, THIS EXPLAINS WHY THE STRAP IS IN BAD SHAPE. THE MANUFACTURER CONCLUDES THE LIFT SUFFERED A LACK OF MAINTENANCE NOT ONLY REGARDING THE STRAP AND CASING, BUT ON SEVERAL OTHER PARTS OF THE LIFT AS WELL (I.E. HANDSET AND WIRE PLUG). THIS LACK OF MAINTENANCE RESULTED IN COMPROMISING THE SAFETY OF THE PATIENT AND THE USER AS CLEARLY SPECIFIED IN THE OPI. IF MAINTENANCE AND SPECIFIED VERIFICATIONS (AS INDICATED IN THE OPI) HAD BEEN DONE CORRECTLY AND ON A REGULAR BASIS, THIS INCIDENT COULD HAVE BEEN AVOIDED. THE CUSTOMER SHOULD HAVE ALL SIMILAR PRODUCTS INSPECTED AND REPAIRED (IF NEEDED) BY A QUALIFIED TECHNICIAN AND THESE ACTIONS RECORDED. ALL PRODUCTS AT THE SITE SHOULD BE MAINTAINED ACCORDING TO THE OPI MANUAL AND BY QUALIFIED PERSONNEL. IT IS RECOMMENDED ALL PERSONNEL USING THE LIFTS SHOULD BE RETRAINED IN THE PROPER USE AND MAINTENANCE OF THE EQUIPMENT.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE TRANSFER OF THE RESIDENT TO THE WHEELCHAIR WAS ALMOST COMPLETED. ABOUT TWO SECONDS INTO LOWERING THE RESIDENT ONTO THE WHEELCHAIR, THE STRAP SNAPPED AND THE PATIENT FELL. THE PATIENT LANDED ON THE BACKREST OF THE WHEELCHAIR. THE CASSETTE FELL BUT DID NOT HIT OR CONTACT THE RESIDENT IN ANY WAY. NO INJURIES WERE REPORTED. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI SKY 440 CEILING LIFT FNG BHM MEDICAL, INC. LEXXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1