COVIDIEN-NEW VENTILATOR

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anonymous said:
Is there a new 980 recall?
Click to expand...
Not a recall

March 25, 2022 Urgent Medical Device Safety Notice Puritan Bennett™ 980 Series Ventilator Attention: Risk Management, Directors of Respiratory Care, Critical Care Units Dear Valued Customer: The purpose of this letter is to advise you that Medtronic is issuing a safety notice related to all serial numbers of Puritan Bennett™ 980 (PB980) series ventilators. Reason for this safety notice This voluntary medical device safety notice is being issued following receipt of seventeen reports from customers stating that during alarm conditions, the audible alarm may not sound and/or the omnidirectional LED visual alarm may not illuminate as described in the operator's manual. The associated visual alarm banner(s) continues to display as expected on the graphic user interface (GUI). A visual display of the alarm banner(s) on the GUI without expected audible alarm or omni-directional LED visual alarm indicates that these alarms have failed. Failure of the audible alarm to sound and/or the omni-directional LED visual alarm to illuminate does not impact ventilator operation. In the event the audible alarm fails to sound and/or the omni-directional LED alarm fails to illuminate, the clinical team should transfer the patient to another form of ventilation. Following transfer of a patient to another form of ventilation, the PB980 ventilator can be power cycled to reset inoperable audible and visual alarms; while this restores proper alarm operation for a period of time, note that power cycling may not prevent recurrence of inoperable alarms. No patient harm has occurred in association with the seventeen customer reports. In thirteen of seventeen customer reports, it was stated that the patient was transferred to an alternate source of ventilation with no patient harm. The frequency of occurrence for this issue is improbable and corresponds to an annual rate of 0.05%. Based on our internal review, including the rate of occurrence for the reports, Medtronic is advising that continued use of PB980 ventilators is appropriate when the actions listed below are taken into consideration, unless this continued use is inconsistent with your facility's internal policies and procedures. Risk to health
 










































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