BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWLIFE INTENSITY 10

    MDR report key: 10145423 · Received June 11, 2020

    Report

    Report Number
    3004972304-2018-00043
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    August 3, 2018
    Report Date
    July 24, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K960309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. NO DAMAGE WAS OBSERVED TO THE EXTERIOR OR INTERIOR OF THE CONCENTRATOR. RED DUST WAS OBSERVED ON THE BASE OF THE CONCENTRATOR. THE GRINDING NOISE COMING FROM THE CONCENTRATOR WAS DETERMINED TO BE A FAILED COMPRESSOR MOTOR BY INSPECTION OF ALL MECHANICAL COMPONENTS OF THE COMPRESSOR. NO HEAT OR OTHER DAMAGE WAS OBSERVED.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 7/24/2019, AND IS BEING RESUBMITTED ON 6/18/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. CLIENT'S WIFE REPORTED THAT SHE HAD A VERBAL CONVERSATION WITH STAFF ON JULY 19 REQUESTING THAT HER HUSBAND'S INTENSITY BE REPLACED SINCE IT SOUNDED VERY LOUD. STAFF REPORTED THAT HE WOULD HAVE THE INTENSITY SWITCHED OUT THE NEXT DAY ON JULY 20 BUT THAT DID NOT OCCUR NOR WAS SHE CONTACTED ABOUT AN ALTERNATE DATE. THE CLIENT'S SPOUSE WAS GOING TO CALL THE OFFICE AGAIN SINCE THEIR RETURN FROM A FAMILY EVENT IN (B)(6) SINCE THE GRINDING FROM THE CONCENTRATOR HAD NOT ABIDED. HOWEVER, ONCE SHE NOTED THE BLACK DISCOLORATION ON THE CARPET BENEATH THE CONCENTRATOR SHE BECAME QUITE CONCERNED AND CONTACTED THE ON-CALL THERAPIST. YES, CLIENT HAS A NEW MACHINE IN USE CURRENTLY.

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING 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 9/14/2018, AND IS BEING RESUBMITTED ON 6/11/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. CLIENT'S WIFE REPORTED THAT SHE HAD A VERBAL CONVERSATION WITH STAFF ON (B)(6) REQUESTING THAT HER HUSBAND'S INTENSITY BE REPLACED SINCE IT SOUNDED VERY LOUD. STAFF REPORTED THAT HE WOULD HAVE THE INTENSITY SWITCHED OUT THE NEXT DAY ON (B)(6) BUT THAT DID NOT OCCUR NOR WAS SHE CONTACTED ABOUT AN ALTERNATE DATE. THE CLIENT'S SPOUSE WAS GOING TO CALL THE OFFICE AGAIN SINCE THEIR RETURN FROM A FAMILY EVENT IN SASKATCHEWAN SINCE THE GRINDING FROM THE CONCENTRATOR HAD NOT ABIDED. HOWEVER, ONCE SHE NOTED THE BLACK DISCOLORATION ON THE CARPET BENEATH THE CONCENTRATOR SHE BECAME QUITE CONCERNED AND CONTACTED THE ON-CALL THERAPIST. YES, CLIENT HAS A NEW MACHINE IN USE CURRENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607012 NEWLIFE INTENSITY 10 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. AS099-101

    Patients

    Seq Age Sex Outcome Treatment
    1