BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWIFTHOOK

    MDR report key: 8161683 · Received December 13, 2018

    Report

    Report Number
    3009481053-2018-00049
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 18, 2018
    Report Date
    December 13, 2018
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TO FIND THE UNDERLYING CAUSE FOR THE PRODUCT FAILURE, THE BROKEN SAMPLE WAS PHOTOGRAPHED AND SENT TO MANUFACTURER R&D DEPARTMENT FOR ANALYSIS. THE TECHNICAL DOCUMENTS SURROUNDING THE PRODUCT WERE REVIEWED, AND IT SHOWS THAT THE PRODUCT IS MADE BY INDUSTRIAL FORGING. MATERIAL COMPOSITION STRUCTURE FLAWS USING THIS MANUFACTURING METHOD IS VERY RARE. ACCORDING TO THE PICTURES TAKEN OF THE BROKEN SAMPLE, IT WAS QUICKLY CONCLUDED THAT IT WAS FROM AN OLDER DESIGN THAN THE CURRENT ONE IN PRODUCTION. THE CURRENT DESIGN DATES TO AUGUST OF 2011 WHERE IT WAS REVISED AND WAS IMPROVED WITH A FEATURE TO INCREASE ITS SAFETY. THIS CAME INTO PRODUCTION SHORTLY AFTER. THE OTHER SAMPLES OF THE OLD DESIGN FOUND IN THE QUARANTINE WERE SENT TO THIRD PARTY TESTING LAB FOR DEEPER ANALYSIS. THE ANALYSIS WAS SPLIT INTO TWO TESTS; TENSILE STRENGTH TEST AND MATERIAL COMPOSITION ANALYSIS. DURING THE TENSILE STRENGTH TEST, SAMPLE A WITHSTOOD 30.7KN BEFORE FRACTURE VERSUS SAMPLE B WHICH WITHSTOOD 23.3KN. THE MATERIAL COMPOSITION FOUND IN THE MATERIAL ANALYSIS PROVED SAMPLE A TO BE MATCHED OR SIMILAR, SAMPLE B MATCHED TO S355 OR SIMILAR. CONCLUSION: ALTHOUGH THE SAMPLES HAD DIFFERENT MATERIAL COMPOSITIONS, THE FACTS STAND AS THE MINIMUM FORCE BEFORE FRACTURE WAS 23.3KN. LN COMPARISON TO THE PATIENT WEIGHT 131KG (COLLECTED FOR INVESTIGATION) WHICH IS ALMOST 18 TIMES HIGHER THAN THE PATIENT WEIGHT. THE ANALYSIS REPORT CLEARLY SHOWS THAT THE PRODUCT SWIFTHOOK IS PROPERLY DIMENSIONED FOR ITS PURPOSE AND SHOULD BE ABLE TO WITHSTAND THE LOAD. EVEN THOUGH THE MATERIAL IS DURABLE ENOUGH TO WITHSTAND HIGHER LOADS, THE FAILURE COULD NOT BE DETERMINED IN THIS INCIDENT. THE PRODUCT SWIFTHOOK HAS BEEN SOLD FOR MANY YEARS ON THE MARKET AND HAS FAILED ONLY DURING THIS EVENT. BY THIS, THE CONCLUSION CAN BE DRAWN THAT THE PROBABILITY FOR THE FAILURE OF SWIFTHOOK IS DETERMINED TO BE EVEN LESS THAN 0.005%.

    Description of Event or Problem · 0

    THE USER WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR WHEN THE SWIFTHOOK (COMPONENT) WHICH ATTACHES THE SLING BAR TO THE MOBILE LIFT FRACTURED. THE PATIENT FELL AS THE SLING BAR AND SLING DETACHED FROM THE MOBILE LIFT, BUT DID NOT SUSTAIN ANY INJURY FROM THE EVENT.

    Additional Manufacturer Narrative · 1

    HANDICARE AB HAS INITIATED AN INVESTIGATION FOR THIS EVENT. CORRECTIVE ACTIONS ARE PENDING INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE USER WAS BEING TRANSFERRED FROM BED TO WHEELCHAIR WHEN THE SWIFTHOOK (COMPONENT) WHICH ATTACHES THE SLING BAR TO THE MOBILE LIFT FRACTURED. THE PATIENT FELL AS THE SLING BAR AND SLING DETACHED FROM THE MOBILE LIFT, BUT DID NOT SUSTAIN ANY INJURY FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000992 SWIFTHOOK PATIENT LIFT FSA HANDICARE AB 70200008

    Patients

    Seq Age Sex Outcome Treatment
    1