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The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic respiratory & monitoring solutions announces a voluntary recall of a battery pack used with the capnostream"20 and capnostream"20p patient monitor due to the battery pack might experience thermal runaway with the potential of fire risk to the monitor.
조치
Medtronic sent an Urgent Medical Device Recall letter dated April 2016, by postal mail or courier to all affected customers. The letter instructed users to remove and properly dispose of current batteries. If product was further distributed customers were instructed to forward the recall letter. Customers were asked to completed and return the Acknowledgement and Receipt Form by fax or email. Customers with questions should contact Technical Services at 800-635-5267, option 1, ten 1 and 1 or by email at HQTSWEB@COVIDIEN.com.
For questions regarding this recall call 303-876-8859.
Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Product was also distributed worldwide. There is 1 VA customer.
제품 설명
Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. || Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during intra-hospital transfer of patients. The Capnostream"20 and Capnostream"20p is a combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments
“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.