BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALTER LABS AIRE ELITE COMPRESSOR

    MDR report key: 7594505 · Received June 12, 2018

    Report

    Report Number
    3000219639-2018-00004
    Event Type
    Death
    Date Received
    June 12, 2018
    Date of Event
    May 1, 2018
    Report Date
    June 12, 2018
    Manufacturer
    SALTER LABS
    Product Code
    CAF
    PMA / PMN Number
    K050104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SALTER LABS RECEIVED A NOTICE OF CLAIM REGARDING A FIRE AT THEIR INSUREDS HOME. THE COMPRESSOR WAS ONE OF SEVERAL ELECTRICAL DEVICES IN THE VICINITY OF THE ORIGIN OF THE FIRE (OTHER DEVICES INCLUDED AN OXYGEN CONCENTRATOR, AN ELECTRIC BLANKET, ETC.) THERE HAS BEEN NO DETERMINATION REGARDING THE ORIGIN OF THE FIRE. INITIAL PHOTOGRAPHIC EVIDENCE SHOWS THAT THE COMPRESSOR LABEL IS NOT DAMAGED, INDICATING THAT IT IS UNLIKELY TO BE THE SOURCE OF THE FIRE. THE DEVICE WILL NOT BE RETURNED TO SALTER LABS, SO FURTHER INVESTIGATION IS NOT AVAILABLE AT THIS TIME. BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT, IT IS HIGHLY UNLIKELY THAT THE COMPRESSOR IS THE SOURCE OF THE FIRE. THE COMPRESSOR DELIVERS ROOM AIR; WHEREAS THE OXYGEN CONCENTRATOR DELIVERS OXYGEN, WHICH SUPPORTS COMBUSTION. PHOTOGRAPHIC EVIDENCE SHOWS THAT THE COMPRESSOR APPEARS INTACT.

    Description of Event or Problem · 1

    A FIRE OCCURRED WHICH RESULTED IN A DEATH. A SALTER ELITE COMPRESSOR 8350-1 WAS ONE OF SEVERAL DEVICES LOCATED IN THE AREA OF ORIGIN OF THE FIRE. AT THIS TIME IT IS UNKNOWN IF THE COMPRESSOR WAS THE CAUSE OF THE FIRE AND NO FURTHER INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434212 SALTER LABS AIRE ELITE COMPRESSOR COMPRESSOR CAF SALTER LABS 8350 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death