BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEC, O2 SENSOR, 700/800/980 MAXTEC

    MDR report key: 4295777 · Received December 3, 2014

    Report

    Report Number
    2025525-2014-00116
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CARLSBAD (700) -RX
    Product Code
    CCL
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEFECTIVE OXYGEN SENSOR THAT WAS REFERENCED IN THIS COMPLAINT WAS A FAILURE OUT OF BOX. A FAILURE OUT OF BOX IS DETERMINED DURING DEVICE SERVICING AND IS OBVIOUS TO THE PERSON SERVICING THE DEVICE. DEVICE SERVICING IS NEVER PERFORMED DURING PATIENT USE. THIS IS NOT CONSIDERED AN MDR REPORTABLE EVENT. COVIDIEN REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ASR GENERATED. PLEASE REF ASR-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779816 SPEC, O2 SENSOR, 700/800/980 MAXTEC NONE CCL CARLSBAD (700) -RX

    Patients

    Seq Age Sex Outcome Treatment
    1