BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIRST BREATH ADULT THREE IN ONE MASK

    MDR report key: 1308803 · Received February 6, 2009

    Report

    Report Number
    9680866-2009-00001
    Event Type
    Death
    Date Received
    February 6, 2009
    Date of Event
    December 1, 2008
    Report Date
    February 5, 2009
    Manufacturer
    MANUFACTURED FOR SMITHS MEDICAL ASD, INC. BY: UNOMEDICAL INC.
    Product Code
    BYG
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THAT THE COMPLAINT SAMPLE WAS NOT RETAINED FOR EVALUATION BY THE HOSPITAL, THE INVESTIGATION OF UNOMEDICAL WAS LIMITED TO THE FOLLOWING SOURCES OF INFORMATION: INFORMATION PROVIDED BY THE CUSTOMER (CUSTOMER INCIDENT REPORT FORM). EXAMINATION OF SAMPLES FROM THE CURRENT PRODUCTION. EXAMINATION OF BATCH RECORDS AND COMPLAINT HISTORY FOR THIS PRODUCT. THE HOSPITAL REPORTED IN THE CUSTOMER INCIDENT REPORT FORM THAT A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE DETACHMENT OF THE OXYGEN TUBE IS UNKNOWN. THE HOSPITAL ALSO STATED THAT THE DEATH COULD BE CAUSED BY THE PATIENT'S CONDITION AND NOT TO THE TUBE DETACHMENT. EXAMINATION OF CURRENT PRODUCTION SAMPLES INDICATED THAT THE PRODUCT IS MEETING THE SPECIFICATIONS REQUIREMENTS AND THE BATCH RECORDS DEMONSTRATE THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. NO SIMILAR QUALITY PROBLEMS WERE OBSERVED DURING IN-PROCESS AND FINAL INSPECTION. A 3-YEAR HISTORICAL REVIEW OF COMPLAINTS REVEALED THIS TO BE THE FIRST COMPLAINT FOR THIS PRODUCT LOT. THOUGH THERE HAVE BEEN TWO SIMILAR COMPLAINTS FOR DISCONNECT DURING THE PAST THREE YEARS, THESE DID NOT INDICATE A SYSTEMATIC FAILURE DURING MANUFACTURE. GIVEN THE ABOVE WE CAN CONCLUDE THAT THERE IS NO EVIDENCE THAT THE PRODUCT WAS THE CAUSE OF THE UNFORTUNATE OUTCOME OF THIS INCIDENT. RESULTS OF INVESTIGATION DEMONSTRATED THAT THE PRODUCT HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. THIS REPORT WILL BE LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    IN EARLY 2009, UNOMEDICAL WAS NOTIFIED BY SMITHS MEDICAL ASD, INC. ABOUT AN EVENT WHERE THE HOSPITAL REPORTED THAT THEY HAD THE OXYGEN MASK PRESSED TO THE PATIENT'S FACE. A FEW DAYS LATER, THE OXYGEN TUBE DETACHED FROM THE MASK. THEY REATTACHED THE TUBE AGAIN; HOWEVER, THE PATIENT DIED. THE PATIENT WAS IN THE LAST STAGE CANCER. THE HOSPITAL FEELS THAT THE DEATH WAS CAUSED BY THE PATIENT'S CONDITION AND NOT TO THE TUBE DETACHMENT. THE EVENT TOOK PLACE AT CANCER CENTER, OTHER COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST BREATH ADULT THREE IN ONE MASK OXYGEN MASK BYG MANUFACTURED FOR SMITHS MEDICAL ASD, INC. BY: UNOMEDICAL INC. 001423 08-13 (PRESUMED)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK