BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUPAC PARAPAC PLUS VENTILATOR

    MDR report key: 11792376 · Received May 7, 2021

    Report

    Report Number
    3012307300-2021-04044
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Report Date
    May 7, 2021
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PNEUPAC PARAPAC PLUS VENTILATOR WAS RECEIVED WITH NO PHYSICAL DAMAGE FOUND ON THE DEVICE. FUNCTIONAL TEST WAS PERFORMED AND THE REPORTED ISSUE WAS ABLE TO BE CONFIRMED. AS A RESULT OF CHECKING INTERNAL PARTS, 10 MBAR PRESSURE SWITCH CABLE WAS CUT. THE ISSUE WAS CAUSED BY A MANUFACTURING ERROR. THE ELECTRICAL CHASSIS 530K1109NJP, INCLUDING THE CABLE HARNESS AND THE 10 MBAR PRESSURE SWITCH WERE REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING THE USE OF A SMITHS MEDICAL PNEUPAC PARAPAC PLUS VENTILATOR, A LOW PRESSURE ALARM KEPT SOUNDING. ALSO, THE CMV MODE INDICATOR DID NOT ILLUMINATE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691352 PNEUPAC PARAPAC PLUS VENTILATOR VENTILATOR BTL

    Patients

    Seq Age Sex Outcome Treatment
    1