Events

Alerte De Sécurité sur EXTERNAL DEFIBRILLATORS / MONITORS (1) MODEL3500B HEART STREAM XLT, (2) MODEL M5500B LAERDAL HEARTSTART 4000, (3) MODEL 4735 HEARTSTREAM XL NOS. OF SERIES (1 AND 2) US00100100 To 00101521 (3) ALL USES. SERIES BELOW US00100778

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    7
  • Date
    2001-03-14
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    Under certain circumstances, you may fail to turn on electricity or it is possible to turn off due to a dysfunctional capacitor in the unit circuit.
  • Action
    THE MANUFACTURER STARTED WITHDRAWAL ON 5 FEBRUARY 2001. IDENTIFY AND INSULATE THE PRODUCT. AGILENT RECOMMENDS: (1) ALERT OPERATORS OF POSSIBLE DYSFUNCTION. (2) AGILENT WILL PHONE MARCH-APRIL TO COME REPAIR. IF ANOTHER PRODUCT IS NOT AVAILABLE, FOLLOW THE FOLLOWING INSTRUCTIONS TO REDUCE THE RISK OF FAULTS. THE FOLLOWING TEST IS ONLY REQUIRED ONCE AND IS MORE EFFECTIVE AT THE MAXIMUM TEMPERATURE THAT THE EQUIPMENT IS SUPPLIED TO OPERATE, UNTIL IT IS REPAIRED. (1) WITH THE UNIT TURNED OFF, INSERT YOUR NEW BATTERY COMPLETELY CHARGED, SWITCH ON THE AC OR DC UNIT IN THE ELECTRICITY AND WAIT UNTIL YOU SEE THE GREEN SIGN ON THE ELECTRICITY MODULE. (2) TURN ON THE UNIT AND WAIT UNTIL MONITOR LIGHTING FOR AT LEAST 10 SECONDS AND SWITCH OFF. (3) REMOVE THE BATTERY AND DISCONNECT ELECTRICITY. (4) TURN ON THE UNIT (NOTE THAT IT DOES NOT LIGHT) AND TURN OFF. LEAVE IT OFF FOR 1 MINUTE. (5) RE-INSERT THE SAME BATTERY. (6) TURN ON THE UNIT, AND WAIT UNTIL MONITOR LIGHTING FOR AT LEAST 10 SECONDS AND SWITCH OFF. (7) REMOVE THE BATTERY. (8) REPEAT STAGES 4 TO 7 FIVE TIMES. (9) RUN THE SHIT / SYSTEM TESTER (SEE YOUR INSTRUCTION MANUAL) AND MAKE SURE THAT THE UNIT PERFORMED IN VERIFICATION. AGILENT ALSO SUGGESTS THAT WHEN POSSIBLE, LEAVE THE DC OR AC UNIT ON THE ELECTRICITY SO THAT IT IS NECESSARY TO INSERT BATTERY DURING USE. IF YOU NEED BATTERY, ALWAYS HAVE A COMPLETELY LOADED RESERVE. AFTER ANY BATTERY INSERTION, TEST THE UNIT: CALL AND SEE IF THE MONITOR IS LIGHTED, THEN IF THE PRODUCT IS NOT IN USE IN A PATIENT AND SWITCH OFF. FOR FURTHER INFORMATION, TELEPHONE TO LOCAL AGILENT.

Device

EXTERNAL DEFIBRILLATORS / MONITORS (1) MODEL3500B HEART STREAM XLT, (2) MODEL M5500B LAERDAL HEAR...

Manufacturer

AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP
  • Source
    ANVSANVISA