Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Medtronic Puritan Bennett 980 Series Ventilator [All serial numbers] [HKMD No.: 170080].
According to MHRA, the voluntary medical device safety notice is being issued by the manufacturer following reports from seventeen customers stating that during alarm conditions, the audible alarm may not sound and/or the omni-directional LED visual alarm may not illuminate as described in the Operator 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 restores proper alarm operation for a period of time, note that power cycling may not prevent recurrence of inoperable alarms.
According to the manufacturer, in the event of a failure of a PB980 ventilator audible alarm and/or a failure of the omnidirectional LED visual alarm, a clinician’s awareness of the alarm condition may be delayed if the GUI banner visual alarm is not noticed in a timely manner. This delayed awareness can lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
For further information, please visit https://mhra-gov.filecamp.com/s/1efx55KEKfdB7hQw/d
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 Apr 2022