BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM6

    MDR report key: 2896421 · Received November 20, 2012

    Report

    Report Number
    1218950-2012-03827
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT WHEN A PT BEING TREATED FOR TACHYCARDIA WAS CONNECTED TO THE VM6 PT MONITOR THE HEART RATE VALUE DISPLAYED AS 140 TO 150 BEATS PER MINUTE. THE STAFF WAS CONSIDERING TREATMENT WITH A BETA-BLOCKER; HOWEVER, THE SPO2 VALUE AND PULSE RATE DID NOT CORRESPOND TO THE DISPLAYED HEART RATE VALUES. THE PT WAS CONNECTED TO A PULSE OXIMETER WHICH SHOWED DIFFERENT VALUES THAN THE MONITOR. NO PT HARM WAS REPORTED. THE MONITOR WAS SHIPPED TO THE PHILIPS SERVICE PROVIDER THIRD PARTY SERVICE CENTER WHERE THE REPAIR TECHNICIAN REPORTED THAT THE MONITOR MAIN BOARD NEEDED TO BE REPLACED. THE REPAIR TECHNICIAN REPLACED THE MONITOR MAIN BOARD TO RESTORE FULL FUNCTION TO THE MONITOR. THIS ISSUE DOES NOT REPRESENT AN EARLY FAILURE, THE MONITOR WAS SHIPPED TO THE CUSTOMER (B)(6) 2007. THE TRENDING DATA DOES NOT SUPPORT THAT THERE IS ANY MANUFACTURING, DESIGN, LABELING, MATERIALS OR SUPPLIER PROBLEM. THE FAILED MAIN BOARD WAS REPLACED TO RESOLVE THE ISSUE AND RESTORE FULL FUNCTION TO THE MONITOR. THE MONITOR WAS REPAIRED AND RETURNED TO THE CUSTOMER. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN A PT BEING TREATED FOR TACHYCARDIA WAS CONNECTED TO THE VM6 PT MONITOR THE HEART RATE VALUE DISPLAYED WAS 140 TO 150 BEATS PER MINUTE. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VM6 MHX PHILIPS MEDICAL SYSTEMS 863064

    Patients

    Seq Age Sex Outcome Treatment
    1