Events

Recall of Device Recall SERVOi ventilator system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Cardiovascular Us Sales, Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64645
  • Event Risk Class
    Class 1
  • Event Number
    Z-1177-2013
  • Event Initiated Date
    2013-03-07
  • Event Date Posted
    2013-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116703
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    When using the servo-i on battery power, in a very small number of cases, some battery modules distributed after january 31, 2010 have a shorter battery run time than expected.
  • Action
    The firm, Maquet Getinge Group" sent "Field Safety Notices"/"Field Safety Notice Confirmation Forms" dated March 7 & 11 2013 via Federal Express and an updated Field Safety Notices dated April 15, 2013 to its customers. The Field Safety Notices identifies the problem, product, risk factors and actions to be taken by the customer. The customers were instructed to reconnect the ventilator to mains power immediately or add additional battery modules in case of 'low battery voltage' alarm; ensure that at least two fully charged batteries are installed at all times, and that sufficient resuscitation equipment is accessible to the ventilator; identify and immediately replace battery modules with date codes 1005-1243, that have generated either: a "low battery voltage" alarm or a "replace battery" message, prior to the expiry date; and complete and return the enclosed Field Safety Notice Confirmation Form by e-mailing a scanned copy to FieldActions@maquet.com or via fax at (973) 807-1832. If you have any questions or require replacement batteries, please contact your local MAQUET representative, or MAQUET Customer Service at 888-627-8383 (press option 2, followed by option 3) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Device

Device Recall SERVOi ventilator system
  • Model / Serial
    SERVO-i Battery Module part number is 6487180. Notice pertains to Battery Modules manufactured between February 2010 and October 2012 with date codes between 1005 and 1243.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CUBA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, YUGOSLAVIA (Former), FIJI, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LIBYA, LITHUANIA, LUXEMBURG, MACAU, MACEDONIA, MALAYSIA, MALDIVES, MARTINIQUE (French), MEXICO, MOLDAVIA, MOROCCO, NEPAL, NETHERLANDS, NEW CALEDONIA (French), NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, POLYNESIA (French), PORTUGAL, QATAR, REUNION (French), ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SEYCHELLES, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SUDAN, SURINAM, SWEDEN, SWITZERLAND, SYRIA, TADJIKISTAN, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VATICAN city state, VENEZUELA, VIETNAM and YEMEN.
  • Product Description
    Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). || Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Manufacturer Address
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA