BEUDAMED
    FDA Adverse Event Other Summary report: N

    STROLLER G3 PB

    MDR report key: 1029625 · Received April 8, 2008

    Report

    Report Number
    3004822415-2008-00002
    Event Type
    Other
    Date Received
    April 8, 2008
    Date of Event
    November 1, 2007
    Report Date
    March 10, 2008
    Manufacturer
    CAIRE, INC.
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2007, REP (USER FACILITY TECHNICIAN) CALLED TECHNICAL SERVICE REPRESENTATIVE OF CAIRE INC., REP STATED THAT "UNIT IN VINYL CASE WITH TOWEL WRAPPED AROUND. REP TOOK OUT OF CASE AND VISUALLY INSPECTED. SEES NOTHING WRONG WITH THE UNIT. COILS ARE ALL OK. NO DENTS TOWEL WAS USED TO COLLECT MOISTURE". WITH THE ABOVE INFORMATION AND INFORMATION IN APPENDIX I & II, THE CAIRE INC.'S QA/RA MANAGER CONCLUDED THAT THE DEVICE HAD NEVER MALFUNCTIONED. THE USER DID NOT FOLLOW PATIENT OPERATING INSTRUCTIONS (POI) WHICH STATES "KEEP YOUR UNIT IN A WELL-VENTILATED AREA". THE HEALTHCARE PROVIDER HAS BEEN ADVISED TO PROVIDE TRAINING TO HIS STAFF ACCORDING TO MANUFACTURER SUPPLIED POI. THEREFORE, I REQUEST TO CLOSE THE CASE AS NO FURTHER INVESTIGATION IS REQUIRED UNLESS ADVISED BY FDA. NOTE: THIS INCIDENT WAS NOT REPORTED TO THE FDA IN 2007 BECAUSE IT DID NOT MEET THE REPORTING CRITERIA PER OUR UNDERSTANDING OF FDA GUIDELINES. HOWEVER, AS A RESULT OF A RECENT FDA AUDIT, WE HAVE BEEN REQUESTED TO SUBMIT THIS INCIDENT REPORT AS THE FDA AUDITOR BELIEVES THAT THIS WAS A REPORTABLE INCIDENT.

    Description of Event or Problem · 1

    PER HEALTH CARE PROVIDER "PORTABLE WAS FILLED AT 9:00 AM BY AIDE AND WAS REFILLED AT 11:00 AM. SHORTLY THEREAFTER, LOX EXITED VIA FLOW CONTROL VALVE THROUGH CANNULA AND TO PATIENT". LOX BURNS ALONG ROUTE OF CANNULA, FROM THROAT TO BEHIND EARS, OVER CHEEKS AND TO NOSTRILS. THE INJURY WAS NOT LIFE THREATENING IMMEDIATELY, UNLESS COMPLICATIONS DEVELOP. PERMANENT IMPAIRMENT OF BODY FUNCTION OR MEDICAL/SURGICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STROLLER G3 PB PORTABLE BYJ CAIRE, INC. 10564109

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization