BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7200 SERIES MICROPROCESSOR VENTILAT

    MDR report key: 226369 · Received June 3, 1999

    Report

    Report Number
    2024500-1999-00092
    Event Type
    Malfunction
    Date Received
    June 3, 1999
    Report Date
    June 2, 1999
    Manufacturer
    PURITAN BENNETT CORP.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT COMPLAINT REPORT SHOWS THE CUSTOMER ALLEGED THE DEVICE HAD NO AUDIO ALARM AS DESCRIBED BY STAFF. NO PT HARM IS VERIFED. THE RPTR REC'D A THIRD HAND REPORT AND DOES NOT KNOW THE EXACT DATE OF THE REPORTED EVENT. NO ADD'L PT INFO IS AVAILABLE TO THE MFR FROM THE FACILITY. THE CUSTOMER BIOMED WAS ABLE TO GENERATE AN INTERMITTENT ALARM BY WIGGLING THE WIRES TO THE POWER SWITCH. THE CUSTOMER DOES HIS OWN REPAIRS AND WILL REPLACE THE SWITCH AS SOON AS ONE ARRIVES. HE PLANS TO RETURN THE OLD SWITCH FOR EVALUATION. THE CUSTOMER DID NOT KNOW WHEN THE SWITCH WAS LAST REPLACED DURING THE 10 K PM AS THE CUSTOMER DID NOT HAVE THE DEVICE RECORDS AT THE TIME OF THE CALL. HE DOES NOT BELIEVE THERE IS A SIGNIFICANT SVC HISTORY. IT IS NOT VERIFIED THAT THERE WAS NO ALARM, AND NO MALFUNCTION MAY HAVE OCCURRED. THIS REPORT IS NOT AN ADMISSION BY NELLCOR PURITAN-BENNETT THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT ALLEGED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7200 SERIES MICROPROCESSOR VENTILAT VOLUME VENTILATOR CBK PURITAN BENNETT CORP. 7200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN