BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8010762-2019-00078

    MDR report key: 8448641 · Received March 25, 2019

    Report

    Report Number
    8010762-2019-00078
    Event Type
    Malfunction
    Date Received
    March 25, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 25, 2019
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REFERENCE EXEMPTION # E2018002. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). ACCORDING TO THE SERVICE ORDER REPORT # (B)(4) DATED ON 2019-03-08 THE SERVICE TECHNICIAN PERFORMED AS FOLLOWS: "SERVICE ORDER OPENED AFTER RECEIVING AN ERROR MESSAGE, CUSTOMER REPORTED ERROR 1 WAS RECEIVED. POWERED UP ROTAFLOW RECEIVED ERROR 4.1, HEAD ERROR. CHECKED HEAD CONNECTION, HEAD CONNECTION OK. FOUND FAULTY FUSE ON POWER SUPPLY BOARD. REPLACED FUSE, FUSE BLEW AFTER POWER UP. REPLACED FUSE AND DISCONNECTED HEAD, POWERED UP FUSE DID NOT BLOW. INFORMED CUSTOMER HEAD WOULD NEED REPLACING AND THE REPAIR WOULD BE EXECUTED THROUGH THE DEPOT. CUSTOMER DECIDED TO NOT REPAIR THE EQUIPMENT AT THIS TIME. NO CHECKLIST COMPLETED EQUIPMENT IS TAGGED OUT OF SERVICE NOT FUNCTIONING". A ROOT CAUSE COULD NOT BE DETERMINED THUS THE FAILURE COULD NOT BE CONFIRMED. FURTHER INVESTIGATIONS CONCERNING THE FAILURE "HEAD ERROR" ARE CARRIED OUT WITH THE NC-(B)(4).

    Description of Event or Problem · 0

    (B)(4). IT WAS REPORTED, THAT AFTER THE CUSTOMER RECEIVED A MESSAGE "ERROR 1" A SERVICE ORDER WAS OPENED AND THE TECHNICIAN FOUND DURING POWERING UP THE ROTAFLOW A "HEAD ERROR". NO KNOWN IMPACT TO THE PATIENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention