BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S2800 SERIES MAXI-CHAIR

    MDR report key: 1008987 · Received March 6, 2008

    Report

    Report Number
    1937051-2008-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2008
    Date of Event
    February 20, 2008
    Manufacturer
    GLOBAL SURGICAL CORP.
    Product Code
    HME
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: CASTING INTEGRITY COMPROMISED BY A SUBSEQUENT MACHINING OPERATION. CONCLUSIONS: INCIDENT WAS DIRECTLY CAUSED BY FAILURE OF SUPPORT CASTING. EXPLANATION. FAILED DEVICE WAS NOT RETURNED. UNIT NOT RELEASED BY HOSP.

    Description of Event or Problem · 1

    IN 2008, GLOBAL REC'D A CALL FROM ONE OF OUR FIELD REP THAT A 6 FOOT 5 INCH PT WEIGHING APPROX 325 POUNDS HAD FALLEN OUT OF AN EXAMINATION CHAIR WHEN A CAST IRON STRUCTURAL BACK SUPPORT FAILED ALLOWING THE CHAIR BACK TO FALL BEYOND ITS FULL RECLINE POSITION. AS A RESULT OF THE EVENT, THE PT BUMPED HIS HEAD ON THE FLOOR. THE PT WAS EXAMINED AND MRI RESULTS WERE FOUND TO BE NORMAL. GLOBAL IMMEDIATELY MADE A DECISION TO STOP PRODUCTION OF THE S2800 CHAIR UNTIL FURTHER INVESTIGATION HAD BEEN COMPLETED. PARTS WERE RANDOMLY SELECTED FROM PRODUCTION AND X-RAYED BY AN INDEPENDENT METALLURGICAL TEST LAB. RESULTS SHOWED NO OBVIOUS POROSITY OR IMPURITIES IN THE CASTING THAT WOULD HAVE CONTRIBUTED TO THE FAILURE. GLOBAL ENGINEERING WAS ABLE TO DUPLICATE THE FIELD FAILURE ON TWO PRODUCTION CHAIRS BY ADDING 340 AND 372 POUNDS TO THE CHAIR BACKS WHILE THE CHAIRS WERE IN FULL RECLINE POSITION. GLOBAL ENGINEERING DESIGNED A REINFORCING BRACKET THAT WOULD PREVENT COMPLETE SEPARATION OF THE CASTING IN THE EVENT OF A FAILURE AND WOULD PREVENT THE CHAIR FROM EXCEEDING ITS FULL RECLINE POSITON WITH THEN BRACKET ADDED, THE CASTING MEMBER WAS SUBJECTED TO 498 POUNDS BEFORE IT FAILED. THE ADDED BRACKET PREVENTED THE CHAIR FROM FALLING PAST ITS FULL RECLINE POSITION AND ALLOWED IT TO CONTINUE TO CYCLE THROUGH FULL RANGE OF FUNCTIONS. SUPPORT CASTING TO BE REDESIGNED TO PROVIDE GREATER STRENGTH. REINFORCING BRACKET TO BE INSTALLED ON ALL CHARS THAT ARE CURRENTLY IN THE FIELD AND THOSE BEING MANUFACTURED UNTIL REDESIGN CASTING BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S2800 SERIES MAXI-CHAIR MEDICAL ENT EXAMINATION CHAIR HME GLOBAL SURGICAL CORP. S280000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA