BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 1881562 · Received October 19, 2010

    Report

    Report Number
    9610816-2010-00534
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Report Date
    September 22, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR#: (B)(4). THE CUSTOMER REPORTED THAT THEY RECEIVED A VISUAL ALARM BUT NO AUDIO ALARM. NO PATIENT HARM WAS REPORTED. PRELIMINARY INVESTIGATION SUPPORTS THAT A USER HAD SILENCED THE ALARM AND THEREFORE SUPPORTS THAT THE MONITOR WAS WORKING AS INTENDED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    PR#: (B)(4). THE CUSTOMER REPORTED THAT ON (B)(6) 2010, AND BETWEEN 3 00 AM AND 4 00 AM, THE MONITOR IN ROOM/BED # 3A DID NOT ALARM AUDIBLY FOR A BRADY CONDITION. THE CUSTOMER NOTICED THE VISUAL RED ALARM BUT NOT THE AUDIBLE SOUND. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO INVESTIGATE THE ISSUE. HE TESTED THE MONITOR WITH A SIMULATOR AND OVER AN EXTENDED PERIOD OF TIME, BUT COULD NOT DUPLICATE THE ISSUE. THE MONITOR WORKED AS INTENDED AND PER ITS SPECIFICATIONS. AFTER TALKING TO THE STAFF AND LOOKING AT THE MONITOR ALARM LOGS, THE PHILIPS FSE STATED THE FOLLOWING "ONSITE WAS YESTERDAY TO GET ALL THE LOGS AND TO TEST THE MONITOR. THE MONITOR WORKED AS SPECIFIED, ALL ALARMS, INCLUDING ESPECIALLY HR ALARMS, WERE ANNOUNCED VISUALLY AND AUDIBLE. ADDITIONALLY THE FSE FOUND ALL ALARMS FROM THE SPECIFIC TIMEFRAME IN THE ALARM. REVIEW LOG OF THE MONITOR IN THIS LOG IT CAN BE SEEN, THAT EVERY ALARM DURING THIS TIME WAS IMMEDIATELY SILENCED. THE MONITOR DID ANNOUNCE THE ALARM, BUT THE ALARM WAS SILENCED BY THE USER". WHEN ALARMS ARE SILENCED AS IN THIS CASE, AND PER PRODUCT LABELING, THERE WILL BE NO AUDIBLE SOUND, BUT ONLY VISUAL ALARMS OFF SYMBOL AND THE RED ALARM LAMP ON THE FRONT PANEL WILL BE LIT. BASED ON THE AVAILABLE DATA, WE CONCLUDE THAT THE MONITOR WORKED AS INTENDED AND ALARMED PER ITS SPECIFICATIONS. THE MONITOR IS CURRENTLY IN USE AT THE CUSTOMER'S SITE. NO OTHER CALLS WERE LOGGED BY THIS SITE FOR THIS ISSUE, AND NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED A VISUAL ALARM BUT NO AUDIO ALARM. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351538 MP70 INTELLIVUE PATIENT MONITOR DSI DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown