BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD BASE UNIT

    MDR report key: 221716 · Received May 4, 1999

    Report

    Report Number
    1525725-1999-00005
    Event Type
    Injury
    Date Received
    May 4, 1999
    Date of Event
    March 31, 1999
    Report Date
    April 30, 1999
    Manufacturer
    OHIO MEDICAL INSTRUMENT
    Product Code
    HAW
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A CALL WAS REC'D BY OHIO MEDICAL INSTRUMENT (OMI) ON 04/06/99 FROM AN OMI REP STATING THAT RN CONTACTED HIM AND SAID THERE HAS BEEN AN EVENT WHERE A BASE UNIT SLIPPED UNDER 60 LBS OF TRACTION WEIGHT. OMI REP STATED THAT HE EVALUATED THE UNIT AND SAID THE CAM ROD WAS BENT AND THE UNIT MOVED DURING THE 45 DEGREE TEST. THE RN CONTACTED OMI ON THE 7TH AND SHE WAS ASKED ABOUT THE POST-OPERATIVE CONDITION OF THE PT AND IF THE BASE UNIT WAS AVAILABLE FOR EVALUATION. SHE SAID THE PT, AT THIS TIME, SEEMED TO HAVE SOME PARALYSIS. SHE ALSO STATED THAT THE BASE UNIT IN QUESTION WAS AVAILABLE FOR EVALUATION AND IT WOULD BE SENT TO OMI. IF THE CO HAD ANY OTHER QUESTIONS, THE CO SHOULD TALK TO A STAFF EDUCATOR. STAFF EDUCATOR WAS ALSO CONTACTED ON 04/07 AND ASKED ABOUT THE EQUIPMENT, SHE STATED THAT IT WOULD NOT HOLD THE WEIGHT AND ASKED WHAT THE UNITS WERE RATED. THE CO ASKED ABOUT THE BENT CAM ROD AND SHE SAID IT WAS POSSIBLE AND ASKED HOW THAT HAPPENED. THE CO TOLD HER ABOUT THE POSITION OF THE HANDLE IN RELATIONSHIP TO THE BEARING PINS. THE CO TOLD HER THE CO WOULD SEND HER A DIAGRAM AND A DEVICE EVENT REPORT THAT THE CO WOULD LIKE HER TO FILL OUT. THESE WERE SENT ON 04/08. A BASE UNIT WAS REC'D ON 04/08 FOR REPAIR AND IT CONTAINED A BENT CAM ROD. ON 04/12 A CALL WAS MADE ASKING WHERE TO SEND THE REPORT AND WHETHER TO REPAIR THE UNIT OR NOT. ON 04/21 A MED WATCH WAS REC'D AND THE DATE CODE DID NOT MATCH THE UNIT REC'D BY OMI ON 04/08. WHEN THE USER FACILITY WAS ASKED ABOUT THE UNIT CO HAD THEY SAID NO IT WAS NOT THE UNIT AND THE ONE IN QUESTION WAS BEING HELD BY LEGAL. TO DATE, THE CO HAS NOT SEEN THAT UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD BASE UNIT BASE UNIT HAW OHIO MEDICAL INSTRUMENT UNK 957

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability