Events

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 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 AGILENT TECHNOLOGIES INC. HEALTHCARE SOLUTIONS GROUP 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    7
  • 날짜
    2001-03-14
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    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.
  • 조치
    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