BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRWAY PRESSURE MONITOR

    MDR report key: 510136 · Received February 6, 2004

    Report

    Report Number
    2518422-2004-00005
    Event Type
    Death
    Date Received
    February 6, 2004
    Date of Event
    March 22, 2000
    Report Date
    January 8, 2004
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED REGARDING AN ALLEGATION THAT MEDICAL EQUIPMENT SUPPLIED TO A PT WAS DFECTIVELY PROVIDED AND/OR MAINTAINED AND OTHERWISE MALFUNCTIONED AND/OR BECAME INOPERATIVE WHILE IN PT USE. THE ALLEGED PROBLEM WITH THE EQUIPMENT OCCURRED ON OR ABOUT 3/2000 PROXIMATELY CAUSING THE DEATH OF THE PT TWO DAYS LATER. IT IS UNCLEAR WHICH OF THE PRODUCTS ALLEGEDLY MALFUNCTIONED. IT IS UNCLEAR IF THE EQUIPMENT WAS IN PT USE AT THE TIME OF DEATH. PRIOR TO THIS EVENT, THE UNIT WAS RETURNED FOR SERVICE IN 11/1999 AND WAS RETURNED TO THE CUSTOMER OPERATING TO SPECIFICATION. AFTER THIS EVENT, THE UNIT WAS RETURNED FOR ROUTINE SERVICE IN 8/2000. THERE WAS NO REPORT OF PT HARM AT THAT TIME. DURING THE REPAIR EVAL, IT WAS DISCOVERED THAT THE GAUGE HAD BEEN OVER-PRESSURED. THE GAUGE WAS REPLACED TO CORRECT THE PROBLEM AND THE UNIT WAS RETURNED TO THE CUSTOMER OPERATING TO SPECIFICATION. THE EQUIPMENT IS NOT CURRENTLY AVAILABLE FOR INVESTIGATION. THE ALARM SETTINGS AT THE TIME OF THE ALLEGED MALFUNCTION ARE UNK. IT IS UNK AT THIS TIME WHETHER A DEVICE FAILURE HAD ACTUALLY OCCURRED AND IF SO, WHETHER THERE WAS ANY ASSOCIATION BETWEEN ANY SUCH FAILURE AND THE PT EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRWAY PRESSURE MONITOR MONITOR, AIRWAY PRESSURE (INCLUDING GAUGE AND/OR ALARM) CAP RESPIRONICS, INC. 332259 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death