BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MHX,DRT

    MDR report key: 1511082 · Received September 29, 2009

    Report

    Report Number
    1218950-2009-01410
    Event Type
    Injury
    Date Received
    September 29, 2009
    Date of Event
    September 24, 2009
    Report Date
    September 24, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT A PT BECAME APNEIC AND EXPERIENCED A LIFT THREATENING EVENT, REQUIRING RESUSCITATION FOR 5-7 MINUTES. WE WILL CONSIDER THIS TO REPRESENT A SERIOUS INJURY. THOUGH THE CUSTOMER STATED THEY DID NOT GET AN APNEA ALARM, THE STRIPS AND LOGS SHOW THAT THE VIFIB/TACH ALARM OCCURRED AT 03:11, WHICH WAS BEFORE THE MONITOR DETECTED APNEA, THEREFORE, NO DELAY IN TREATMENT OCCURRED. THE VFIB/TACH WAS RESPONDED TO BY STAFF WHEN IT OCCURRED. THE FSE HAS INDICATED THAT ON ARRIVAL, THE RESPIRATION ALARMS WERE OFF FOR THIS BED, WHICH WOULD PREVENT RESPIRATION ALARMS OF ANY KIND FROM BEING ANNUNCIATED. THIS IS THE DEFAULT CONFIGURATION AT THIS HOSPITAL. POST INCIDENT TESTING FOUND THE DEVICE ALARMING ON COMMAND. THE AVAILABLE INFO DOES NOT SUPPORT THAT A DEVICE MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT BECAME APNEIC AND EXPERIENCED A LIFT THREATENING EVENT, REQUIRING RESUSCITATION FOR 5-7 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MHX,DRT PHILIPS INFORMATION CENTER NETWORK DATABASE MHX PHILIPS MEDICAL SYSTEMS 865011 (M3155)

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR