BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLINDER,ULTRAFILL,MD22,3000 PSI

    MDR report key: 11856667 · Received May 20, 2021

    Report

    Report Number
    2518422-2021-01505
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 22, 2021
    Report Date
    February 6, 2024
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CAW
    PMA / PMN Number
    K091191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A CYLINDER BECAME DISCONNECTED FROM THE ULTRAFILL DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR EVALUATION. THE MANUFACTURER CONFIRMED THE BURST DISK VALVE HAD EVIDENCE OF CORROSION. THE MANUFACTURER CONFIRMED THE BURST DISK RUPTURED IN THE CYLINDER CAUSING THE CYLINDER TO OUTGAS.

    Additional Manufacturer Narrative · 0

    ON THE PREVIOUSLY SUMMITTED REPORT, THE DEVICE PROBLEM CODE WAS MISSING FROM THE REPORT. IT IS CORRECTED ON THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A CYLINDER BECAME DISCONNECTED FROM THE ULTRAFILL DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR EVALUATION. THE MANUFACTURER CONFIRMED THE BURST DISK VALVE HAD EVIDENCE OF CORROSION. THE MANUFACTURER CONFIRMED THE BURST DISK RUPTURED IN THE CYLINDER CAUSING THE CYLINDER TO OUTGAS. ANALYSIS OF PAST EVENTS HAS NOT INDICATED AN ADVERSE EVENT HAS OCCURRED DUE TO CORROSION. REVIEW OF THE RISK FILE INDICATES THE POTENTIAL FOR A SERIOUS ADVERSE EVENT OCCURRING AS A RESULT OF THIS INCIDENT IS UNLIKELY. ADDITIONALLY, THE RISK FILE INDICATES THAT CORROSION WILL NOT SUBSTANTIALLY AFFECT THE PERFORMANCE OF THE DEVICE. THIS COMPLAINT IS CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CYLINDER BECAME DISCONNECTED FROM THE ULTRAFILL DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755496 CYLINDER,ULTRAFILL,MD22,3000 PSI GENERATOR, OXYGEN, PORTABLE CAW PHILIPS RESPIRONICS INC. 1065721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ULTRAFILL, SN (B)(6).| ULTRAFILL, SN (B)(4).