BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PM4150 EASY PULSE POC

    MDR report key: 9536069 · Received December 31, 2019

    Report

    Report Number
    2523148-2019-00003
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Report Date
    January 27, 2019
    Manufacturer
    PRECISION MEDICAL INC
    Product Code
    CAW
    UDI-DI
    00855887006078
    PMA / PMN Number
    K103563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT "(B)(6) FIRE RESCUE DEPARTMENT - AFRD# (B)(4)" RECEIVED FROM MEDMARC INSURANCE COMPANY ATTACHED. UNKNOWN IF PRECISION MEDICAL PM4150 PORTABLE OXYGEN CONCENTRATOR WAS INVOLVED? REPORT INDICATES "OXYGEN MACHINE" USER INDICATED AS NOTED IN PREVIOUS SUBMISSION THE DEVICE WAS THROWN IN THE TRASH (BY WHO UNKNOWN). "ATLANTA FIRE RESCUE DEPARTMENT - AFRD#: (B)(4)" REPORT INDICATES THE FOLLOWING: AFTER A SYSTEMATIC REVIEW OF THE FIRE SCENE AND ANY AVILABLE DOCUMENTS, PHOTOS, VIDEOS OR STATEMENTS, IT IS MY CONCLUSION THAT THE FIRE ORGINATED IN THE BEDROOM DUE TO UNKNOWN CIRCUMSTANCES. I HAVE TWO HYPOTHESES FOR THIS INCIDENT THAT I UNABLE TO CONFIRM. 1. THERE WAS A MECHNICAL OR ELECTRICAL FAILURE IN THE OXYGEN MACHINE THAT IGNITED THE COMBUSTIBLES IN THE ROOM. 2. MR. GRIMES WAS SMOKING AND WAS CARLESS WITH ONE OF HIS CIGARETTES CAUSING THE COMBUSTIBLES IN THE ROOM TO IGNITE. AT THIS TIME, I AM UNABLE TO CONFIRM EITHER OF MY HYPOTHESES AND WILL BE CLASSIFYING THIS FIRE AS UNDETERMINED. - ATTACHMENT: [(B)(6) FIRE & RESCUE DEPT INCIDENT REPORT (B)(4)).PDF]

    Description of Event or Problem · 0

    END USER CLAIMS PM4150 PORTABLE OXYGEN CONCENTRATOR CAUSED FIRE DAMAGE TO HOME UNKNOWN IF PRECISION MEDICAL PM4150 PORTABLE OXYGEN CONCENTRATOR GIVEN BY PATIENT WAS INVOLVED.

    Additional Manufacturer Narrative · 1

    USER OF PM4150 PORTABLE OXYGEN CONCENTRATOR (SN (B)(4)) CONTACTED PRECISION MEDICAL INC ON 12/10/2019 INDICATING THE DEVICE CAUGHT FIRE AND DAMAGED HIS HOME. USER ORIGINALLY CLAIMED HIS HOUSE BURNED DOWN. USER INDICATED HE HEARD A HISSING NOISE AND SEEN THE FIRE. USER WAS DIFFICULT TO UNDERSTAND AND AT ONE POINT INDICATED SOMETHING ABOUT HIS WALLS BEING BLACK OR TO SOME SORT. USER CLAIMED HE HAD NO INSURANCE AND WAS CONTACTING PRECISION MEDICAL INC TO FILE A CLAIM. USER INDICATED THE DEVICE WAS THROWN IN THE TRASH (BY WHO UNKNOWN). USER INDICATED HE HAD NO REPORT TO SEND TO PRECISION MEDICAL INC. USER DID NOT KNOW THE NAME OF THE FIRE DEPARTMENT HE CLAIMED CAME TO HIS HOUSE; HOWEVER PROVIDED #38 & #22. PRECISION MEDICAL INC CONTACTED MEDMARC INSURANCE COMPANY TO INVESTIGATE THE VALIDITY OF THE CLAIM. AS OF 12/13/2019; MEDMARC INSURANCE COMPANY WAS ABLE TO CONTACT THE FIRE COMPANY WHICH CONFIRMED THERE WAS NO CONFIRMED FIRES AT THE ADDRESS SUPPLIED BY THE USER. MEDMARC WAS UNABLE TO REACH THE USER VIA TELEPHONE WITH NUMEROUS CALLS AND VOICE-MAILS. MEDMARC INSURANCE COMPANY IS SENDING A LETTER TO THE USER TO OBTAIN ADDITIONAL INFORMATION AND DETERMINE THE VALIDITY OF THE CLAIM

    Description of Event or Problem · 1

    END USER CLAIMS PM4150 PORTABLE OXYGEN CONCENTRATOR CAUSED FIRE DAMAGE TO HOME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331044 PM4150 EASY PULSE POC PM4150 EASY PULSE POC CAW PRECISION MEDICAL INC PM4150 111918 00855887006078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention