BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 1022200 · Received March 26, 2008

    Report

    Report Number
    9617021-2008-00010
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    December 14, 2007
    Report Date
    March 12, 2008
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFTER WAS INSPECTED; NO DEFICIENCES WERE NOTED ON THE LIFTING DEVICE. NO PRODUCTION DATE OR SERIAL NUMBER WAS RECEIVED FOR THE SLING. HOWEVER, PICTURES RECEIVED SHOWED A CLIP IN "AS NEW" CONDITION APART FORM A CRACK RUNNING FROM THE TOP OF THE KEYHOLE OPENING TO BELOW THE TOP BAR OF THE CLIP. STRESS CALCULATIONS AND PULL-TO-BREAK TESTS ON THIS TYPE OF CLIP HAVE SHOWN THAT TYPICAL BREAKAGE ON OVERLOAD OCCURS LEFT AND RIGHT OF THE TOP BAR OF THE CLIP IN A HORIZONTAL FASHION AND NOT IN A VERTICAL FASHION FROM THE KEYHOLE TO THE OPENING UNDER THE TOP BAR AS SHOWN IN THE PICTURE. THIS INDICATES THAT THE CRACK THAT OCCURRED IN THIS EVENT DID NOT STEM FROM A SUBSTANDARD CLIP FAILING DURING NORMAL USE. TO FAIL IN THIS WAY, IT IS LIKELY THAT THE CLIP SUSTAINED HAIRLINE FRACTURES BY BEING DEFORMED IN A PROCESS OUTSIDE OF NORMAL USE, SUCH AS (BUT NOT LIMITED TO) THE WASHING OR DRYING PROCESS. EVEN IN NORMAL USE, THE HAIRLINE FRACTURE CAN THEN DEVELOP INTO A CRACK WHEN STRAINED. THE SLING IS TO BE RETURNED TO THE MFR; ANY FINDINGS FROM THE EVALUATION OF THE SLING THAT DIFFER FROM THESE WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE WASHING LABEL AND SLING INSTRUCTION SHEET CLEARLY INDICATE THAT NO PRESSING IS ALLOWED. IT HAS BEEN INDICATED BY THE INVESTIGATOR THAT NOTHING SEEM WRONG WITH THE WASHING PROCEDURE. THIS, HOWEVER, DOES NOT EXCLUDE THE POSSIBILITY OF THE DEFORMATION PREVIOUS TO USE HAVING OCCURRED IN THIS PROCESS OR POSSIBLY ANOTHER SIMILAR PROCESS OUTSIDE OF NORMAL USE THAT THE MFR IS UNAWARE OF. IT WAS REPORTED THE CARER WAS A HEALTHCARE PROFESSIONAL, LAST TRAINED IN 2005. THE LIFTER OPERATING AND PRODUCT CARE INSTRUCTIONS (OPI) AND SLING INSTRUCTIONS SHEET INDICATE THE SLING AND CLIPS SHOULD BE CHECKED FOR WEAR AND SUITABILITY BEFORE EACH AND EVERY USE. IF DEFORMATION OF THE CLIPS OCCURS, WHITE LINES ARE VISIBLE, IT APPEARS THAT WHEN THE PT WAS MOVED FROM A SEATED TO A SEMI-RECUMBENT POSITION, PLACING MORE STRAIN WAS PUT ON THE SHOULDER CLIPS. THE RIGHT HAND SHOULDER CLIP, WHICH IS BELIEVED TO HAVE BEEN DEFORMED BEFORE THE USE, CRACKED ALONG AN EXISTING HAIRLINE FRACTURE IN AN ATYPICAL FASHION, ALLOWING THE CLIP TO SLIP OVER THE HANGER BAR ATTACHMENT POINT, CAUSING THE PT TO ALMOST DROP. FROM THE INFO RECEIVED AND GATHERED, THE MFR CONCLUDES THE MOST LIKELY ROOT CAUSE FOR THE CLIP FAILURE WAS THE CLIP HAVING BEEN DEFORMED BY A PROCESS OUTSIDE OF NORMAL USE. THE MFR SUGGESTS THAT THE CUSTOMER REVIEW THE WASHING PROCESS AND, IF NO STAGE IS FOUND WHERE THE CLIP ENCOUNTERS ABNORMAL STRESS, OTHER PROCESSES SHOULD BE REVIEWED TO PREVENT THE CLIPS ON SLINGS FROM BEING DEFORMED AND HAIRLINE FRACTURES FROM OCCURRING. IT IS ALSO SUGGESTED THAT CARERS USING THE PRODUCT BE RETRAINED TO THE OPI ON A REGULAR BASIS, IN THIS INSTANCE WITH PARTICULAR ATTENTION TO THE "CHECK BEFORE USE" POLICY OF THE CLIP.

    Description of Event or Problem · 1

    THE FACILITY REPORTS, DURING TRANSFER OF THE PT FROM THE CHAIR TO THE BED, THE RIGHT SHOULDER SIDE CLIP CRACKED. THE STAFF GRABBED THE STRAP ON THE SLING TO PREVENT THE RESIDENT FROM FALLING WHILE CALLING FOR ASSISTANCE TO AID IN LOWERING THE PT TO THE BED. THE STAFF FELT STIFFNESS IN THE PT'S RIGHT SHOULDER BUT NO FURTHER INJURIES. THE SHOULDER DID NOT REQUIRE ANY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO PATIENT LIFT FNG ARJO MED AB LTD. KPBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR