BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWLIFE INTENSITY 10

    MDR report key: 10079412 · Received May 21, 2020

    Report

    Report Number
    3004972304-2018-00055
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Report Date
    July 17, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K960309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN." UNIT WAS RETURNED FOR EVALUATION. BASED ON THE RESULTS OF THIS TESTING, THE UNIT WAS FOUND TO BE SAFE TO OPERATE. NO DIRECT CAUSE COULD BE IDENTIFIED THAT WOULD HAVE CREATED THE HIGH TEMPERATURES THAT WERE REPORTED BY THE SERVICE TECHNICIAN. IT IS UNCLEAR WHETHER THE LOOSE PRONG ON THE POWER CORD WAS CAUSED BY THE OVERHEATING OR WHETHER IT CONTRIBUTED TO THE CONDITION. ALTHOUGH THE INTERIOR OF THE UNIT WAS EXTREMELY DIRTY, THERE DID NOT APPEAR TO BE ANY DAMAGE. THE LOUD COMPRESSOR MAY HAVE BEEN A RESULT OF SIGNIFICANT AMOUNTS OF DUST BEING PULLED THROUGH THE SYSTEM BUT NO DEFINITIVE CONCLUSIONS CAN BE MADE. DESPITE THIS ISSUE, THE UNIT WAS ABLE TO MEET THE PURITY LEVELS SPECIFIED IN THE PROCEDURE WITHOUT ALARMING. THIS TESTING DID NOT FIND ANY SAFETY CONCERNS.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 7/17/2019, AND IS BEING RESUBMITTED ON 5/28/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. A TECHNICIAN WENT TO DO A CONCENTRATOR CHECK AT A USER'S HOUSE BECAUSE THE UNIT WAS BEEPING. HE BROUGHT THE UNIT BACK TO (B)(4) TO CHECK. WHEN HE WAS TESTING THE UNIT HE UNPLUGGED THE UNIT AND THEN PLUGGED IT BACK IN, THAT WAS WHEN IT WAS NOTICED THAT THE UNIT WAS REALLY HOT - TOO HOT TO TOUCH. HE NOTICED THAT THE PLASTIC AROUND THE AC PRONGS WAS SLIGHTLY MELTED AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 12/04/2018, AND IS BEING RESUBMITTED ON 5/21/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. A TECHNICIAN WENT TO DO A CONCENTRATOR CHECK AT A USER'S HOUSE BECAUSE THE UNIT WAS BEEPING. HE BROUGHT THE UNIT BACK TO (B)(6) TO CHECK. WHEN HE WAS TESTING THE UNIT HE UNPLUGGED THE UNIT AND THEN PLUGGED IT BACK IN, THAT WAS WHEN IT WAS NOTICED THAT THE UNIT WAS REALLY HOT - TOO HOT TO TOUCH. HE NOTICED THAT THE PLASTIC AROUND THE AC PRONGS WAS SLIGHTLY MELTED AND DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545031 NEWLIFE INTENSITY 10 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-100

    Patients

    Seq Age Sex Outcome Treatment
    1