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Terminated

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

FDA Recall Z-0497-2019 · Posted 2018-12-18

Recalling FirmCOVIDIEN LLC
Recall StatusTerminated
Product CodeCBK
Date Initiated2018-09-18
Date Terminated2021-02-01
Product Quantity9,593

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017-10-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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