BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MOLIFT

    MDR report key: 15015473 · Received July 14, 2022

    Report

    Report Number
    3004137175-2022-00001
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 18, 2022
    Report Date
    June 18, 2022
    Manufacturer
    ETAC A/S
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ETAC HAS RECEIVED AN INCIDENT REPORT FROM A CUSTOMER WHERE A QUICK RELEASE COUPLING AS PART OF THE PATIENT LIFTING SYSTEM HAS COME APART DURING USE. THIS QUICK RELEASE COUPLING MALFUNCTION MAY POTENTIALLY CAUSE THE FALL OF THE PATIENT DURING TRANSFER. ETAC HAS DECIDED TO ISSUE A FIELD SAFETY NOTICE COVERING THIS ISSUE. THE FIELD SAFETY NOTICE COVERS MANUFACTURING PERIOD 03/21/2022 TO 06/21/2022. INVESTIGATION OF THE NONCONFORMING QUICK RELEASE COUPLING SHOWED THAT THE ADHESIVE SECURING THE QUICK RELEASE COUPLING WAS NOT SUFFICIENTLY CURED CAUSING THE QUICK RELEASE COUPLING TO BE ABLE TO COME APART. DURING USE IT IS POSSIBLE TO DETECT IF THE QUICK RELEASE COUPLING HAS BECOME NONCONFORMING AS THE TWO MAIN PARTS INCLUDED IN THE QUICK RELEASE COUPLING WILL HAVE A GAP. IN CASE OF DETECTED MALFUNCTION THE CUSTOMER HAS BEEN INSTRUCTED TO STOP USING THE DEVICE UNTIL SERVICE HAS BEEN COMPLETED. A REPLACEMENT KIT WITH SUFFICIENT ADHESIVE WILL BE FORWARDED TO ALL INVOLVED CUSTOMERS WITH THE EXPLANATORY INFORMATION ON HOW TO PERFORM CORRECT REPLACEMENT WITH A SAFETY CHECK BEFORE USE OF THE NEW QUICK RELEAS COUPLING.

    Additional Manufacturer Narrative · 0

    ETAC HAS RECEIVED AN INCIDENT REPORT FROM A CUSTOMER WHERE A QUICK RELEASE COUPLING AS PART OF THE PATIENT LIFTING SYSTEM HAS COME APART DURING USE. THIS QUICK RELEASE COUPLING MALFUNCTION MAY POTENTIALLY CAUSE THE FALL OF THE PATIENT DURING TRANSFER. ETAC HAS DECIDED TO ISSUE A FIELD SAFETY NOTICE COVERING THIS ISSUE. THE FIELD SAFETY NOTICE COVERS MANUFACTURING PERIOD 03/21/2022 TO 06/21/2022. INVESTIGATION OF THE NONCONFORMING QUICK RELEASE COUPLING SHOWED THAT THE ADHESIVE SECURING THE QUICK RELEASE COUPLING WAS NOT SUFFICIENTLY CURED CAUSING THE QUICK RELEASE COUPLING TO BE ABLE TO COME APART. DURING USE IT IS POSSIBLE TO DETECT IF THE QUICK RELEASE COUPLING HAS BECOME NONCONFORMING AS THE TWO MAIN PARTS INCLUDED IN THE QUICK RELEASE COUPLING WILL HAVE A GAP. IN CASE OF DETECTED MALFUNCTION THE CUSTOMER HAS BEEN INSTRUCTED TO STOP USING THE DEVICE UNTIL SERVICE HAS BEEN COMPLETED. A REPLACEMENT KIT WITH SUFFICIENT ADHESIVE WILL BE FORWARDED TO ALL INVOLVED CUSTOMERS WITH THE EXPLANATORY INFORMATION ON HOW TO PERFORM CORRECT REPLACEMENT WITH A SAFETY CHECK BEFORE USE OF THE NEW QUICK RELEASE COUPLING.

    Description of Event or Problem · 0

    DURING TRANSFER OF THE PATIENT FROM THE BED TO THE WHEELCHAIR. WHILE ABOUT 1 METER ABOVE THE FLOOR THE HOIST COUPLING CAME APART AND THE PATIENT FELL TO THE FLOOR.

    Description of Event or Problem · 0

    DURING TRANSFER OF THE PATIENT FROM THE BED TO THE WHEELCHAIR. WHILE ABOUT 1 METER ABOVE THE FLOOR THE HOIST COUPLING CAME APART AND THE PATIENT FELL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861414 MOLIFT AIR QUICK RELEASE COUPLING FSA ETAC A/S 2510363 032122
    470460 MOLIFT AIR QUICK RELEASE COUPLING FSA ETAC A/S 2510363 032122

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female