BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-F 4000 PLUS

    MDR report key: 3960358 · Received June 23, 2014

    Report

    Report Number
    9615050-2014-04139
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 27, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K882594
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THIS WAS DUE TO A LIFTED SOLDER PAD ON THE AUDIO BUZZER WHICH MAY HAVE CAUSED THE VOLUME OUTPUT TO BECOME DISABLED. THE CAUSE OF THE LIFTED SOLDER PAD WAS MECHANICAL STRESS ON THE LEAD OVER TIME. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE SERVICE CTR FOR A REPORT FROM THE CUSTOMER CONTACT OF "ABUSE". THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366256 O-F 4000 PLUS 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA