BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 8221243 · Received January 7, 2019

    Report

    Report Number
    9681684-2019-00001
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    November 17, 2018
    Report Date
    March 1, 2019
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012068 BY THE ARJOHUNTLEIGH MAGOG INC. (REGISTRATION #9681684) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC (AHUS) (REGISTRATION #1419652) ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO ARJO REPRESENTATIVE THAT A PARAPLEGIC PATIENT SUSTAINED AN UNKNOWN FRACTURE, THE CUSTOMER ADVICE THAT THE EVENT OCCURRED DURING TRANSFER. THE FACILITY STAFF DENIED THAT ANY INCIDENT HAS HAPPENED. NO MORE INFORMATION WAS AVAILABLE. THE ARJO REPRESENTATIVE CONTACTED WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO EVENT CIRCUMSTANCES. THE CUSTOMER ADVISED THAT THE PATIENT HAVE OSTEOPOROSIS AND IT IS POSSIBLE THAT INJURY OCCURRED OUTSIDE THE FACILITY WHILE NO LIFT WAS USED. NEVERTHELESS, THERE IS NO CONFIRMATION HOW THE EVENT HAPPENED. AFTER THE EVENT, ARJO SERVICE TECHNICIAN EVALUATED THE DEVICE. THE VISUAL INSPECTION SHOWED A SCRATCH ON THE MAST. THE LIFT WAS IN OVERALL GOOD CONDITION. THE FUNCTIONAL TEST SHOWED THAT THE DEVICE WAS WORKING ACCORDING TO THE MANUFACTURER'S SPECIFICATION- NO MALFUNCTION WAS DETECTED. MOREOVER, THE CUSTOMER FACILITY ASKED FOR ADDITIONAL TRAINING FOR THE STAFF REGARDING SAFELY AND CORRECTLY USE THE ARJO LIFTS. DESPITE THE EFFORT MADE AND ATTEMPTS MADE TO CONTACT THE CUSTOMER. WE DID NOT GET SUFFICIENT AND ADDITIONAL INFORMATION RELATED TO EVENT CIRCUMSTANCES. FOR THIS REASON, THE EXACT ROOT CAUSE CANNOT BE EXPLAINED. IN SUMMARY, THE ROOT CAUSE WAS IMPOSSIBLE TO DEFINE DESPITE THE ANALYSIS OF ALL COLLECTED INFORMATION. THE CUSTOMER REPORTED THAT THE PATIENT SUSTAINED AN INJURY DURING THE TRANSFER. WE REPORT THIS EVENT TO COMPETENT AUTHORITIES DUE TO A MALFUNCTION THAT OCCURRED (SPREADER BAR DETACHMENT DURING USE).

    Additional Manufacturer Narrative · 0

    COLLECTING INFORMATION IS ONGOING. ADDITIONAL INFORMATIONWILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO ARJO REPRESENTATIVE THAT A PARAPLEGIC PATIENT SUSTAINED UNKNOWN FRACTURE, THE CUSTOMER ADVICE THAT EVENT OCCURRED DURING TRANSFER. THE FACILITY STAFF DENIED THAT ANY INCIDENT HAS HAPPENED. NO MORE INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14640 MAXI MOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention