BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON 6001

    MDR report key: 1013899 · Received March 13, 2008

    Report

    Report Number
    MW5005868
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    November 17, 2004
    Report Date
    March 13, 2008
    Manufacturer
    SKYTRON
    Product Code
    BWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM TABLE MALFUNCTION RESULTING IN PT INJURY REQUIRING HOSPITALIZATION AND LEGAL CLAIM AGAINST FACILITY. TABLE EVALUATED BY CONTRACTED THIRD PARTY REPAIR. NOTES INDICATED USER ERROR. HAND CONTROL REPLACED. TABLE RETURNED TO SERVICE PER CONTRACTOR'S EVALUATION. SEVERAL CALLS MADE TO THIRD PARTY CONTRACTOR FOR COMPLAINTS OF TABLE INSTABILITY. NO FAULTS OR TABLE ERRORS FOUND PER FIELD SERVICE REPORTS. TABLE RETURNED TO SERVICE EACH TIME WITH NO ERRORS FOUND PER FIELD SERVICE REPORTS. ON 11/15/2006 TABLE MALFUNCTIONED WITH FAILURE OF THE HYDRAULIC SYSTEM WHILE A 340+ POUND PT WAS ANESTHETIZED ON THAT TABLE. FAILURE OF THE HYDRAULICS CAUSED THE PT TO IMMEDIATELY BEGIN HEADING HEAD FIRST TO THE FLOOR. I CAUGHT THE PT AND SUSTAINED A PERSONAL CERVICAL NECK INJURY WHICH REQUIRED SURGICAL REPAIR. TABLE EVALUATED BY THIRD PARTY CONTRACTORS. FIELD SERVICE REPORT INDICATED USER ERROR. TABLE RETURNED TO SERVICE PER FIELD SERVICE REPORT. IN 2007: THE SAME OPERATING ROOM TABLE MALFUNCTIONED AND LOCKED ITSELF IN THE FULL TABLE UP, TABLE TILT AND LEG DOWN POSITION OVERNIGHT AND ON ITS OWN. THIRD PARTY CONTRACTOR NOTIFIED. PER FIELD SERVICE REPORT RECOMMENDATION: REMOVE TABLE FROM SERVICE DUE TO PERMANENT MALFUNCTION AND NON-REPAIRABLE STATE FOR THE SAFETY OF FUTURE PTS. IN THEIR OWN OPINION, THE TABLE DID IN FACT HAVE UNDERLYING ISSUES ALL ALONG YET BECAUSE OF THE TRANSIENT NATURE OF THE PROBLEMS, IT WAS DIFFICULT FOR THEM TO DIAGNOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON 6001 OPERATING ROOM TABLE- HYDRAULIC BWN SKYTRON 6001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| S