BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVO LITE OCSI

    MDR report key: 2896622 · Received December 28, 2012

    Report

    Report Number
    1039215-2012-00005
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    October 12, 2012
    Report Date
    December 27, 2012
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT WAS REPAIRED AND RETURNED TO HEALTH CARE PROVIDER ON 12/6/2012.

    Description of Event or Problem · 1

    REFER TO FDA REPORT (B)(4). ON THE NIGHT OF (B)(6) 2012 THE NUVO LIGHT OSCI OXYGEN CONCENTRATOR'S LOW OXYGEN ALARM ACTIVATED. THE PT CONTACTED HIS DEVICE PROVIDER THE NEXT MORNING. THE DEVICE PROVIDER IMMEDIATELY DELIVERED A REPLACEMENT RENTAL MACHINE TO THE PT. THE PROVIDER RETURNED THE DEVICE TO NIDEK MEDICAL WHERE IT WAS REC'D ON (B)(6) 2012. UPON INSPECTION, IT WAS DISCOVERED THAT THE NUVO LITE OCSI OXYGEN CONCENTRATOR IN QUESTION HD 5917 HRS OF OPERATION AND A DEFECTIVE COMPRESSOR DELIVERING OXYGEN CONCENTRATION OF 69%. THE COMPRESSOR AND SIEVE BED WERE REPLACED, THE DEVICE WAS TESTED TO ENSURE COMPLIANCE TO PERFORMANCE STANDARDS, AND THEN RETURNED TO THE SUPPLIER ON (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUVO LITE OCSI GENERATOR, OXYGEN PORTABLE CAW NIDEK MEDICAL PRODUCTS, INC. 525

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK