BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATHENA

    MDR report key: 316194 · Received February 13, 2001

    Report

    Report Number
    MW1021082
    Event Type
    Injury
    Date Received
    February 13, 2001
    Date of Event
    January 1, 2000
    Report Date
    February 1, 2001
    Manufacturer
    S & W MEDICO TEKNIK
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ONGOING PROBLEMS WITH ATHENA NEONATAL 9050 MONITOR. DEVICE 1 11/00 MONITOR SHUT DOWN FOR NO APPARENT REASON. DETERMINED THAT MONITOR HAD A "BAD POWER SUPPLY", REPLACED AND POWER WAS RESTORED. DEVICE 2: 11/00 MONITOR SHUT DOWN FOR NO APPARENT REASON. POWER DID NOT RETURN TO MONITOR. CONCLUDED MONITOR HAS A BAD HV DEFLECTION BOARD. DEVICE 3: 11/00, MONITOR SHUT DOWN - INTERNITTENT POWER SUPPLY. DEVICE 4: 11/00, MONITOR SHUT DOWN - INTERMITTEND POWER SUPPLY. DEVICE 5: 11/00, MONITOR SHUT DOWN - HV DEFLECTION BOARD. DEVICE 6: 11/00, MONITOR SHUT DOWN - HV DEFLECTION BOARD. DEVICE 7: 12/00, MONITOR SHUT DOWN - HV DEFLECTION BOARD. DEVICE 8: 12/01, MONITOR HAD ALARM LIMITS SET. EKG ALARM WENT OFF MANY TIMES WHEN NO ALARM CONDITION EXISTED. CONCERNS: CARDIOPULMONARY NEONATAL MONITORS FAILING WITHOUT WARNING, PUTTING THE SAFETY OF THE NEONATES IN JEOPARDY. 8 OUT OF 25 MONITORS HAVE FAILED OVER THE PAST 3 MONTHS. ORIGINAL MFR SOLD THIS LINE OF MONITORS. PARTS ARE DIFFICULT TO OBTAIN. REPLACEMENT PARTS COME FROM OVERSEAS AND USUALLY TAKES 4-5 MONTHS TO RECEIVE THEM. SVC BULLETIN, DATED 10/30/96, WHICH HOSP RECENTLY BECAME AWARE OF, SUGGESTS A FAULTY CAPACITOR (C206) WILL RESULT IN A BLANK SCREEN AFTER THE MONITOR IS SWITCHED ON. BULLETIN IDENTIFIED SERIAL NUMBERS INVOLVED, BUT SOME OF HOSP'S ARE OUTSIDE THOSE NUMBERS. EXTEND OF PROBLEM IS UNKNOWN. NOT CLEAR WHO (MFR/DISTRIBUTOR) OWNS THE PROBLEMS. UNCLEAR IF THERE IS A SECOND PROBLEM. HOSP KNOWS THE CAPACITOR IS CAUSING SOME OF THE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5616 ATHENA NEONATAL BEDSIDE MONITOR 9050 DRT S & W MEDICO TEKNIK * *
    5617 ATHENA NEONATAL BEDSIDE MONITOR 9050 DRT S & W MEDICO TEKNIK * *
    5618 ATHENA NEONATAL BEDSIDE MONITOR 9050 DRT S & W MEDICO TEKNIK * *
    5619 ATHENA NEONATAL BEDSIDE MONITOR 9050 DRT S & W MEDICO TEKNIK. * *
    5620 ATHENA NEONATAL BEDSIDE MONITOR 9050 DRT S & W MEDICO TEKNIK * *
    5621 ATHENA NEONATAL BEDSIDE MONITOR 9050 DRT S & W MEDICO TEKNIK * *
    5622 ATHENA NEONATAL BEDSIDE MONITOR 9050 DRT S & W MEDICO TEKNIK * *
    5623 ATHENA NEONATAL BEDSIDE MONITOR 9050 DRT S & W MEDICO TEKNIK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening