BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERIES IV PHYSIO-MONITORING SYSTEM

    MDR report key: 2888679 · Received December 26, 2012

    Report

    Report Number
    1039368-2012-00003
    Event Type
    Other
    Date Received
    December 26, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 21, 2012
    Manufacturer
    WITT BIOMEDICAL CORP, W HOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC.
    Product Code
    IZI
    PMA / PMN Number
    K033030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED DUE TO MAINTENANCE/USE ERROR BASED UPON INVESTIGATION FINDINGS FROM FSE IN ADDITION TO LABEL REVIEW. INSTRUCTIONS FOR USE AND SERVICE MANUALS WERE ALSO REVIEWED AND AS STATED IN THE CALYSTO SERIES IV USER'S GUIDE, PAGE XXVII REVISION 14, SECTION 38 "WHEN WALL MOUNTS ARE USED TO INSTALL/MOUNT THE DEVICE, IT SHOULD BE NOTED THAT THE CPU MOUNT (PART OF THE WALL MOUNT) SHOULD BE INSTALLED AT OR BELOW THE PT CART/BED LEVEL. IT IS ALSO IMPORTANT TO ENSURE THAT PT CABLES ARE MOVED FROM THE PT AND MOVED AWAY FROM THE PT CART/BED PRIOR TO MOVING THE CART/BED. FAILURE TO FOLLOW THIS RECOMMENDATION COULD RESULT IN PT OR USER INJURY". CALYSTO SERIES IV SERVICE MANUAL PAGE 6-47 REVISION 12 ALSO STATES "PREVENTIVE MAINTENANCE - CUSTOMERS ARE RESPONSIBLE TO IMPLEMENT A PROGRAM OF REGULAR TESTING AND MAINTENANCE FOR CALYSTO SERIES IV DEVICES. FAILURE ON THE PART OF THE CUSTOMER TO IMPLEMENT A SATISFACTORY TESTING AND MAINTENANCE SCHEDULE MAY LEAD TO POTENTIAL EQUIPMENT FAILURE, SAFETY ISSUES, AND POSSIBLE HEALTH HAZARDS TO PTS. AREAS TO BE PERFORMED MONTHLY CONSIST OF AND ARE NOT LIMITED TO: DUST EXTERIOR OF CPUS WITH LINT-FREE CLOTH; CHECK ALL CABLE TERMINATIONS; CONFIRM BOOM MONITOR MOUNTING INTEGRITY, INCLUDING, BUT NOT LIMITED TO BOOM ASSEMBLY MOUNTS, WALL MOUNTS, AND ROLLING STAND MOUNTS. FSE DISPATCHED TO THE SITE NOTED THAT ALL PCMS MOUNTED WERE ABOVE THE RECOMMENDED HEIGHT AND WERE LOOSE. IF THE MONTHLY MAINTENANCE PROGRAM WOULD BE EXECUTED, THE LOOSE CONDITION SHOULD HAVE BEEN NOTED AND PREVENTED.

    Description of Event or Problem · 1

    CUSTOMER SUPPORT PERSONNEL WAS NOTIFIED BY THE ACCOUNT THAT THE PCM FELL OFF THE WALL MOUNT AND FELL ON A NURSE. THERE WAS NO INJURY SUSTAINED TO THE NURSE AND MEDICAL TREATMENT/OBSERVATION WAS REFUSED BY THE NURSE. IT WAS ALSO REPORTED THAT THE SYSTEM WAS RECEIVING AN ERROR OF "NO VIDEO OUTPUT" AFTER THE SYSTEM FELL. CUSTOMER SUPPORT PERSONNEL DISPATCHED FIELD SERVICE ENGINEER (FSE) TO GO ON-SITE TO ASSIST THE ACCOUNT WITH THE LOOSE MOUNTING AND VIDEO OUTPUT. FSE WENT ON SITE AND NOTED THAT THE SYSTEM WAS MOUNTED APPROX 5 FEET OFF FROM THE FLOOR AND CONFIRMED THAT THE UNIT HAD PULLED OUT OF THE GCX WALL MOUNTING FROM THE WALL AND WAS FOUND LOOSE (THE MOUNT SCREWS WERE INTACT, JUST FOUND TO BE LOOSE). THE FSE TIGHTENED ALL MOUNTS ACCORDING TO SPECIFICATION IN ADDITION TO ADDING RUBBER SHIMS TO SECURE THE SYSTEM WITHIN THE MOUNTS. THE FSE ALSO INSTALLED A NEW MAINBOARD KIT, INSTALLED NEW DRIVERS, SET SYSTEM BIOS SETTINGS, WHICH CORRECTED THE VIDEO OUTPUT ISSUE. THE SYSTEM TESTED AND FUNCTIONED AS INTENDED AFTER THE FSE TIGHTENED THE GCX WALL MOUNTS AND REPLACED PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES IV PHYSIO-MONITORING SYSTEM SERIES IV PATIENT CARE MONITOR IZI WITT BIOMEDICAL CORP, W HOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC. 452230033321

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK