BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERIES IV PHYSIO-MONITORING SYSTEM

    MDR report key: 1174589 · Received September 24, 2008

    Report

    Report Number
    1039368-2008-00001
    Event Type
    Other
    Date Received
    September 24, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 23, 2008
    Manufacturer
    WITT BIOMEDICAL CORPORATION, A WHOLLY OWNED SUBSIDIRY OF PHILIPS HOLDING USA, IN
    Product Code
    MWI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER SITE TO EVALUATE THE CUSTOMER COMPLAINT. FSE ONSITE INVESTIGATION RESULTS ARE DOCUMENTED. ENGINEERING DID FORCE TESTING OF THE PATIENT CARE MONITOR (PCM) USING A REPRESENTATIVE SAMPLE OF THE WALL MOUNT USED AT THE CUSTOMER SITE. RESULTS OF THIS FORCE TESTING SHOWED THAT IT TOOK A MINIMUM OF 52.8 LBS OF FORCE TO DISLODGE THE PCM FROM THE WALL MOUNT. REVIEW OF LABELING WAS PERFORMED. IT WAS FOUND THAT THERE WAS NO RECOMMENDATION FOR THE HEIGHT RESTRICTIONS FOR THE CPU WALL MOUNT. RECOMMENDATIONS FOR HEIGHT RESTRICTION WILL BE ADDED TO THE SERIES IV USER'S GUIDE AND SERVICE MANUAL.THIS TYPE OF WALL MOUNT HAS BEEN IN USE SINCE 2002 WITH NO REPORTED ADVERSE EVENTS. EVALUATION RESULTS - PCM WAS DISLODGED AS PATIENT CART WAS MOVED AWAY FROM DEVICE AND PATIENT CABLES WERE CAUGHT IN BED RAILS. THIS WAS FEASIBLE BECAUSE THE PCM WAS FOUND TO BE MOUNTED APPROXIMATELY 7 FEET OFF THE FLOOR WITH THE CABLES HANGING DOWN.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE PCM FELL OFF THE WALL MOUNT DUE TO A LOOSE BRACKET. FURTHER INVESTIGATION REVEALED THAT THE PATIENT'S CABLES WERE DISCONNECTED FROM THE PATIENT AND LAID ON THE PATIENT CART. THE CABLES GOT WRAPPED IN THE RAILS ON THE PATIENT CART. WHEN THEY (2 PEOPLE) MOVED THE PATIENT CART IT PULLED THE CABLES SO HARD THAT THE PCM PULLED OUT OF THE WALL MOUNT AND THE 15-PIN SOLDERED VIDEO CABLE CONNECTOR AND OTHER CABLING WERE YANKED APART FROM THE PCM. THE PERSON WHO CALLED IN ACKNOWLEDGED THAT THE CABLES WERE WRAPPED AROUND THE BED. IT WAS ALSO NOTED THAT THE CPU WALL MOUNT WAS APPROXIMATELY 7 FEET OFF THE FLOOR. WE WERE UNABLE TO DETERMINE IF THE PCM HIT THE FLOOR, HOWEVER, THERE WAS NO PHYSICAL DAMAGE INTERNALLY OR EXTERNALLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER (FSE) REPAIRED THE CABLING AND REMOUNTED THE DEVICE INTO THE WALL MOUNT. THE FSE DID NOTE THAT THE MOUNT SCREWS WERE INTACT AND TIGHTENED AS INTENDED. THE WALL MOUNT WAS NOT LOOSE AS INDICATED BY THE CUSTOMER COMPLAINT. THERE WAS NO PATIENT OR USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES IV PHYSIO-MONITORING SYSTEM SERIES IV PATIENT CARE MONITOR MWI WITT BIOMEDICAL CORPORATION, A WHOLLY OWNED SUBSIDIRY OF PHILIPS HOLDING USA, IN PATIENT CARE MONIT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK