jueves, 21 de abril de 2016

FDA MedWatch - Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage
AUDIENCE: Health Professional, Nursing
ISSUE: Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in its Covidien Oridion labeled Capnostream 20 and Capnostream 20p Patient Monitors. This voluntary recall is being conducted due to a battery manufacturing defect that may increase the risk of thermal damage in the battery pack. The scope of this recall includes battery pack model numbers 016400 and 010520. These packs were manufactured by a contract manufacturer between April 2014 and February 2016. Medtronic has received seven reports of thermal damage out of 9,817 battery packs impacted by this field action. Of these seven reports, one involved a fire resulting in smoke inhalation and minor burns. See firm press release for contact information for Medtronic.
BACKGROUND: Capnostream monitors are external (non-implantable) medical devices used to assess patients’ respiratory status and identify changes in breathing. The prescription device is operated by trained healthcare professionals in a clinical setting and in the home. The company has identified a manufacturing change conducted by the third party contract manufacturer as the probable root cause and is manufacturing new batteries that meet original specifications with a new contract manufacturer. On April 15, 2016, Medtronic sent a letter to customers who have Capnostream battery packs affected by this voluntary recall. The company also supplied a rework kit with full instructions for removal and proper disposal or recycling of the battery pack according to local policy. The eight cell, 14.3 volt, Lithium Ion battery pack is custom manufactured by third party contract manufacturers. The company will supply new batteries to affected customers when available. No other Medtronic products are affected by this supplier of battery packs.
RECOMMENDATION: The company recommends that customers use the Capnostream monitors on AC power (with the battery pack removed) until a replacement battery pack is available.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the firm press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm497049.htm

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