BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARI

    MDR report key: 492408 · Received October 23, 2003

    Report

    Report Number
    MW1029855
    Event Type
    Malfunction
    Date Received
    October 23, 2003
    Date of Event
    January 1, 2003
    Report Date
    October 23, 2003
    Manufacturer
    PARI RESPIRATORY EQUIP., INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER FEELS 2 SAFETY ISSUES RE: DEVICE ARE NOT BEING ADDRESSED BY MFR. 1. MOUTH PIECE HAS 8MM X 17-18 MM RUBBER FLAP THAT DISCONNECTS EASILY. REPORTER HAS FOUND A CHILD WITH THIS IN ITS HAND. 2. SAME FLEXIBLE RUBBER USED FOR INSIDE SCREW CAP. SIZE IS 12 CM WHICH COULD EASILY BE PULLED OFF AND BLOCK CHILD'S AIRWAY. RESPONSE FROM MFR WAS THAT USER SHOULD READ INSTRUCTIONS. MANY OF THE USERS CANNOT OR WILL NOT READ INSTRUCTIONS COMPLETELY. THIS DEVICE IS MAINLY FOR HOME USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARI REUSABLE NEBULIZER WITH TUBING CAF PARI RESPIRATORY EQUIP., INC. LC PLUS *
    2 PARI REUSABLE NEBULIZER WITHOUT TUBING CAF PARI RESPIRATORY EQUIP., INC. LC PLUS *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other