BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 14189567 · Received April 22, 2022

    Report

    Report Number
    3000219639-2022-00022
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 21, 2022
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    UDI-DI
    00607411889097
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION ALONE DOES NOT POSE A FIRE HAZARD BUT THE USE OF OXYGEN INCREASES THE RISK OF FIRE SPREADING THROUGH AN OXYGEN SUPPLY LINE. THE UNIT IN QUESTION IS EXPECTED TO MELT WHEN EXPOSED TO HEAT. THE IGNITION TEMPERATURE OF PVC IS ~851F THEREFORE MAKING IT UNLIKELY THAT THE TUBING COULD HAVE SPONTANEOUSLY COMBUSTED. OPEN FLAMES AND OR IGNITION SOURCES MAY INCLUDE CANDLES, CIGARETTES, CIGARS, FIRE PITS, BARBEQUES, ETC. OXYGEN SUPPLIERS ARE REQUIRED TO PROVIDE WARNINGS OF FIRE HAZARDS WHEN OXYGEN IS IN USE. (I.E., THE JOINT COMMISSION, NATIONAL PATIENT SAFETY GOALS, 2012). EVEN THOUGH THERE WAS NO PATIENT INJURY, OXYGEN TUBING CAUGHT ON FIRE DUE TO PATIENT WALKING WITH TUBING CLOSE TO THE CHIMNEY OUTLET. BASED ON THE INFORMATION ABOVE, THIS WOULD BE A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION ALONE DOES NOT POSE A FIRE HAZARD BUT THE USE OF OXYGEN INCREASES THE RISK OF FIRE SPREADING THROUGH AN OXYGEN SUPPLY LINE. THE UNIT IN QUESTION IS EXPECTED TO MELT WHEN EXPOSED TO HEAT. THE IGNITION TEMPERATURE OF PVC IS 851F THEREFORE MAKING IT UNLIKELY THAT THE TUBING COULD HAVE SPONTANEOUSLY COMBUSTED. OPEN FLAMES AND OR IGNITION SOURCES MAY INCLUDE CANDLES, CIGARETTES, CIGARS, FIRE PITS, BARBEQUES, ETC. OXYGEN SUPPLIERS ARE REQUIRED TO PROVIDE WARNINGS OF FIRE HAZARDS WHEN OXYGEN IS IN USE. (I.E., THE JOINT COMMISSION, NATIONAL PATIENT SAFETY GOALS, 2012). EVEN THOUGH THERE WAS NO PATIENT INJURY, OXYGEN TUBING CAUGHT ON FIRE DUE TO PATIENT WALKING WITH TUBING CLOSE TO THE CHIMNEY OUTLET. BASED ON THE INFORMATION ABOVE, THIS WOULD BE A REPORTABLE EVENT. A FIRE EVENT IS NOT RELATED TO A DEVICE MALFUNCTION. THE PRODUCTS ARE PERFORMING AS EXPECTED: A CONDUIT FOR OXYGEN DELIVERY. THE FIRE IS UNRELATED TO THE PRODUCT ITSELF - IT IS A BY-PRODUCT OF OXYGEN AND AN OPEN-SOURCE FLAME (E.G., SMOKING, CANDLES, SPARKS FROM OTHER SOURCES). IN THIS CASE, THERE WAS AN EMBER CLOSE TO THE TUBING AND WAS IGNITED DUE TO THE OXYGEN SOURCE. THE OXYGEN HAS SAFETY REQUIREMENTS DISPLAYED AND SAFETY SIGNS ARE PROVIDED. NO FURTHER INVESTIGATION IS REQUIRED. ONE OTHER COMPLAINT REGARDING FLAME HAS BEEN REPORTED IN THE LAST 12 MONTHS. PRODUCT WAS REPLACED. SAFETY INFORMATION REVIEWED WITH ACCOUNT BY OXYGEN SUPPLIER. THERE WAS NO MALFUNCTION OF THE SUNMED PRODUCT.

    Description of Event or Problem · 0

    INFLAMMATION OF THE TUBING.

    Description of Event or Problem · 0

    INFLAMMATION OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089083 SALTER LABS PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE) - 25/CS CAT SALTER LABS SO-1188 UNKNOWN 00607411889097

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other