BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1032152 · Received April 21, 2008

    Report

    Report Number
    2031642-2008-00096
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 28, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    RESPIRATORY THERAPY (RT) SUPERVISOR REPORTED THE FOLLOWING: WOUND CARE NURSE ROLLED THE PT ON HER SIDE FOR TREATMENT. UPON ROLLING THE PT, THE VENTILATOR CIRCUIT BECAME DISCONNECTED, AND THE PT'S HEART RATE (HR) DROPPED AND PT BECAME CYANOTIC. THE NURSE REPORTED, THE VENTILATOR DID NOT ALARM UPON DISCONNECT, BUT AN RT ENTERED THE ROOM AND REPORTED THE VENTILATOR WAS ALARMING LOUDLY AUDIBLE. THE PT WAS ROLLED BACK OVER AND THE VENTILATOR CIRCUIT PLACED BACK ONTO THE PT. THE PT'S COLOR AND HR RECOVERED IMMEDIATELY. THE PT SUFFERED NO PERMANENT IMPAIRMENT OR DAMAGE. MFR'S SVC WAS REQUESTED TO ASSESS THE VENTILATOR BASED ON THE NURSES REPORT OF NO ALARM. DURING EVAL AND TESTING THE VENTILATOR FUNCTIONED TO SPECIFICATIONS, INCLUDING ALARMS. THE CUSTOMER SPECULATES THAT THE NURSE PRESSED ALARM SILENCE PRIOR TO ROLLING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention HME