|
Model Number PB980 |
Device Problem
No Flow (2991)
|
Patient Problem
Injury (2348)
|
Event Date 05/23/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Event was received from the food and drug administration (fda) under mw508901 additional information was requested from the fda (food and drug administration).Fda stated, ¿the report that was sent is the copy that provides you with all the allowed releasable information from the report.Unfortunately, we are unable to release any further information that pertains to the report in question." the ventilator product number and serial number were not provided.Additionally, the facility and reporting person were not provided.Therefore, medtronic is unable to further assess this event due to incomplete information.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported via a medwatch report (mw5089013), that while in use on a patient, a 980 ventilator ¿stopped ventilating patient, ventilator did not self activate audible alarms as device is set up to do¿.The report indicates ¿serious injury as the event report type¿ and an ¿event outcome of life threatening¿.Additional information was requested from the fda (food and drug administration).A response from the fda stated, ¿the report that was sent is the copy that provides you with all the allowed releasable information from the report.Unfortunately, we are unable to release any further information that pertains to the report in question.Reporters may elect to not be identified to the device manufacturer, which could explain why fields that may identify the reporter are not included in the copy that was sent.¿.
|
|
Search Alerts/Recalls
|
|
|