BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N595 PULSE OXIMETER

    MDR report key: 1001214 · Received February 22, 2008

    Report

    Report Number
    2936999-2008-00086
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 14, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER HAS DECLINED RETURNING THE DEVICE FOR EVAL. MFG FACILITY HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH THE CUSTOMER REPORTED FAILURE. THE CAPA REFERENCED WAS AN INTERNAL INVESTIGATION, NOT A FIELD ACTION. IF THE DEVICE IS RETURNED FOR INVESTIGATION, RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N595 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA