Events

Field Safety Notices about Puritan Bennett 980 Ventilator

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Covidien LLC.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    1410
  • Date
    2018-01-12
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Extra notes in the data

Device

Puritan Bennett 980 Ventilator
  • Model / Serial
    Catalog Number: 980X3DEDRAC, 980X1DEDRAC, 980X3NLDRAC, 980X1NLDRAC, 980X1FRAIQC, 980X3FRAIQC, 980X1BGDRAC, 980X1ENDRAC, 980X3CSNISC, 980X2FRAIQC, 980X3ENDRAC, 980X2DEDRAC, 980X1ELAIQC, 980X3HUNISC, 980X1ITDIEC 980X3ITDIEC, 980X1HUNISC, 980X1ENNISB 980X3ENNISB, 980X2ITDIEC, 980X1NOAIQC 980X1FIAIQC, 980X1SVAIQC, 980X3PLDIPC 980X1PLDIPC, 980X2PLDIPC, 980X1PTDIPC 980X3PTDIPC, 980X3RODRAC, 980X1RODRAC 980X3SKNISC, 980X1SKNISC, 980X1SLDRAC 980X3ESDIEC, 980X1ESDIEC, 980X2ESDIEC 980X3SVAIQC, 980X1DEDISS, 980X1FRDISS 980X3DEDISS, 980X3TRDRAC, 980X1TRDRAC Batch Number: PB980 Li-ion Battery: Serial Number range: 1201xxxxxx through 1712xxxxxx.
  • Product Description
    Anesthetic and respiratory medical devices
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHSIDCCCDMIS