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U.S. Department of Health and Human Services

Class 1 Device Recall Puritan Bennett 980

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  Class 1 Device Recall Puritan Bennett 980 see related information
Date Initiated by Firm September 18, 2018
Date Posted December 18, 2018
Recall Status1 Terminated 3 on February 01, 2021
Recall Number Z-0497-2019
Recall Event ID 81167
510(K)Number K162738  
Product Classification Ventilator, continuous, facility use - Product Code CBK
Product Puritan Bennett 980 (PB980) ventilator series:
Puritan Bennett" 980 Pediatric Adult Ventilator
Puritan Bennett" 980 Neonatal Ventilator
Puritan Bennett" 980 Universal Ventilator

Product Usage:
The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the followingtypes of ventilator support: Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/ Control, SIMV or Spontaneous modes of ventilation
Code Information Serial Numbers: 35B1300001 through 35B1300051  35B1400003 through 35B1402216   35B1500001 through 35B1502227  35B1600001 through 35B1601408  35B1700001 through 35B1702519  35B1800001 through 35B1801541  35B1400001  35B1601182, 35B1601183, 35B1601193, 35B1601197, 35B1601242 35B1601243, 35B1601245, 35B1702479, 35B1601001, 35B1601089 
Recalling Firm/
Manufacturer		 COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact SAME
508-261-8000
Manufacturer Reason
for Recall		 Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
FDA Determined
Cause 2		 Device Design
Action Medtronic notified U.S. consignees notified via Federal Express or certified mail on September 19, 2018, and the letter informs customers that Medtronic has developed a software update, Maintenance Release (MR) 5.4. Medtronic Service Engineers will load the MR5.4 software during the next scheduled or planned maintenance visit. Immediately notify all care environments in which the PB980 ventilators are used about this notification. " If your facility has distributed PB980 ventilators to other persons or facilities, please promptly forward a copy of this letter to those recipients. " Complete the attached form and return it as directed to confirm your receipt and understanding of this information. Any incidents related to this issue or if you have any questions, please contact our Technical Support Department immediately at 1-800-255-6774. Out--Side US accounts notified by Medtronic Regulatory Partners worldwide on 9/17/18 for translation in their respective country.
Quantity in Commerce 9,593
Distribution Worldwide Distribution - US Nationwide Foreign: Canada Argentina Chile Japan Hong Kong Taiwan Uruguay Austria Austria Azerbaijan Belgium Bosnia And Herzegovina Bulgaria Croatia Czech Republic France Germany Greece Hungary Ireland Israel Italy Kazakhstan Kenya Kuwait Latvia Lebanon Lithuania Netherlands Oman Pakistan Poland Portugal Romania Russian Federation Saudi Arabia Slovakia Slovenia South Africa Spain Sweden Switzerland Tunisia Turkey United Arab Emirates Iran United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = Covidien
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