BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC DISPOSABLE SINGLE LIMB CIRCUIT FOR PNEUPAC DEMAND VENTILATORS 

    MDR report key: 9090331 · Received September 19, 2019

    Report

    Report Number
    3012307300-2019-04991
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    May 27, 2019
    Report Date
    September 20, 2019
    Product Code
    CAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: THE FILE WAS INADVERTENTLY MARKED REPORTABLE. THE EVENT REPORTED UNDER MFR 3012307300-2019-04991-0040004 WAS DETERMINED TO BE NOT REPORTABLE AND NO FURTHER REPORTS WILL BE FILED USING THIS FILE NUMBER. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT AN ABNORMAL NOISE WAS HEARD FROM A SMITHS MEDICAL PNEUPAC DISPOSABLE SINGLE LIMB CIRCUIT FOR PNEUPAC DEMAND VENTILATORS WHILE IN USE WITH A VENTILATOR. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879550 PNEUPAC DISPOSABLE SINGLE LIMB CIRCUIT FOR PNEUPAC DEMAND VENTILATORS  CIRCULATOR, BREATHING-CIRCUIT CAG

    Patients

    Seq Age Sex Outcome Treatment
    1 SMITHS MEDICAL PNEUPAC DEMAND VENTILATOR