BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE 5

    MDR report key: 10121077 · Received June 4, 2020

    Report

    Report Number
    3004972304-2018-00031
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    July 30, 2018
    Report Date
    February 1, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K013931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AN EVALUATION. UPON INVESTIGATION, IT WAS DETERMINED TO BE USER ERROR. AFTER COMPLETION OF AN HHE, IT WAS DETERMINED THAT THERE IS NO RISK OF POTENTIAL INJURY TO THE END USER IF IT WERE TO REOCCUR.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON (B)(6) 2019, AND IS BEING RESUBMITTED ON (B)(6) 2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. ECLIPSE 5 SN (B)(6) WAS RETURNED TO WUPPERTAL FOR STANDARD REPAIR UNDER CASE NUMBER (B)(4) FROM CUSTOMER. REPAIR TECHNICIANS NOTICED BURNS TO PMB/BBB WHEN INSPECTING THE UNIT. REPAIR TECHS NOTIFIED MANAGEMENT. CUSTOMER SENT REPLACEMENT UNIT SO INVESTIGATION CAN BE PERFORMED BY CHART. AWAITING FOR THE CUSTOMER TO RETURN THE POWER SUPPLY USED WITH DEVICE AS PER RECOMMENDATION FROM (B)(6).

    Additional Manufacturer Narrative · 1

    UNIT HAS BEEN RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 8/28/2018, AND IS BEING RESUBMITTED ON 6/4/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. ECLIPSE 5 SN (B)(4) WAS RETURNED TO WUPPERTAL FOR STANDARD REPAIR UNDER CASE NUMBER (B)(4) FROM CUSTOMER. REPAIR TECHNICIANS NOTICED BURNS TO PMB/BBB WHEN INSPECTING THE UNIT. REPAIR TECHS NOTIFIED MANAGEMENT. CUSTOMER SENT REPLACEMENT UNIT SO INVESTIGATION CAN BE PERFORMED BY CHART. AWAITING FOR THE CUSTOMER TO RETURN THE POWER SUPPLY USED WITH DEVICE AS PER RECOMMENDATION FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584651 ECLIPSE 5 CONCENTRATOR, OXYGEN, TRANSPORTABLE CAW CAIRE INC. 6900-C1-SEQ

    Patients

    Seq Age Sex Outcome Treatment
    1