BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNAL RACK

    MDR report key: 39765 · Received September 24, 1996

    Report

    Report Number
    1218950-1996-00006
    Event Type
    Injury
    Date Received
    September 24, 1996
    Date of Event
    September 10, 1996
    Report Date
    September 24, 1996
    Manufacturer
    HEWLETT-PACKARD CO.
    Product Code
    MOY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE INTERNAL RACK WAS RETURNED TO CO FOR ANALYSIS. THE UNIT WAS RECEIVED IN TWO SEPARATE HALVES, SHOWING NO ANOMALIES OR MECHANICAL DEFECTS. ALL FOURTEEN INTERLOCKING TABS APPEARED NORMAL. THE UNIT WAS REASSEMBLED USING THE NORMAL MANUFACTURING PROCESSES. THE EVAL OF THE REASSEMBLED UNIT SHOWED NO ANOMALIES. THE RACK WAS THEN DISASSEMBLED AND MECHANICALLY INSPECTED. NO PROBLEMS WERE DISCOVERED. PULL TESTS ON THE FULLY ASSEMBLED RACK WERE UNSUCCESSFUL IN SEPARATING THE TWO HALVES. THE RACK WAS TURNED OVER TO THE MANUFACTURING ENGINEERING FOR THEIR ANALYSIS. EXPERIMENTS WERE PERFORMED TO INVESTIGATE THE POSSIBILITY THAT THE TOP SEVEN OUT OF FOURTEEN MECHANICAL INTERLOCKS WERE NOT COMPLETELY ENGAGED. THE RESULTS FROM THESE EXPERIMENTS INDICATED THAT WITH THE RACK PARTIALLY ASSEMBLED, THE ELECTRICAL INTEGRITY BETWEEN THE RACK AND RACK INTERFACE CONNECTION IS INTERRUPTED. NO COMMUNICATION BETWEEN THE RACK AND THE CMU WAS POSSIBLE IN THIS PARTIALLY ASSEMBLED STATE. CONCLUSION: THE EXPERIMENTS PERFORMED ON THE RETURNED INTERNAL RACK WERE INCONCLUSIVE. THE RACK EXHIBITED NO SIGNS OF MECHANICAL FATIGUE OR FAILURE. INTENTIONALLY MISASSEMBLING THE RACK RESULTED IN LOSS OF COMMUNICATION BETWEEN THE FRONT END MODULES AND THE CMU. THE CMS IS NOT FUNCTIONAL IN THIS MODE. EQUIPMENT INOP ALARMS WOULD BE GENERATED IN THIS MODE OF OPERATION. THE EQUIPMENT HAS BEEN IN SERVICE FOR TWO YEARS WITH NO REPORTS OF RACK SPECIFIC FAILURES. A REVIEW OF CO'S SERVICE RECORDS DOESN'T SHOW ANY SIMILAR OCCURRENCE OF THIS PROBLEM.

    Description of Event or Problem · 1

    WHILE THE PT WAS BEING MONITORED BY THE M1046A COMPONENT MONITORING SYSTEM, THE M1043-68001 INTERNAL RACK WHICH LOCKS INTO THE COMPUTER MODULE CAME APART. THE FRONT END ASSEMBLY WITH MODULES SEPARATED FROM THE REAR COVER AND FELL UPON THE PT. THE FRONT END ASSEMBLY TURNED IN MID-AIR IN SUCH A MANNER THAT THE CIRCUIT CARD STRUCK THE PT ON THE LEFT SIDE OF THE FACE NEAR THE JAW BONE CAUSING ABRASIONS OF THE SKIN. THE UNIT CONTINUED UNTIL IT STRUCK THE COLLAR BONE IN THE LEFT CLAVICLE AREA, CAUSING A SMALL CUT IN THE SKIN. THE PT WAS GIVEN AN X-RAY EXAMINATION. THERE WERE NO FURTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNAL RACK INTERNAL RACK MOY HEWLETT-PACKARD CO. M1043-68001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other