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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 980
Medical Device Problem Code No Flow (2991)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/05/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: the service engineer (se) inspected the device and could not replicate the reported issue.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that, while in use on a patient, a 980 ventilator suddenly turned itself off.The patient was removed from the ventilator and manually ventilated via an ambu bag before being placed on an alternate ventilator with no harm or injury.
 
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Brand Name
980 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
michael collins road mervue
galway
MDR Report Key8217503
Report Number8020893-2019-00001
Device Sequence Number223284
Product Code CBK
UDI-Device Identifier10884521171749
UDI-Public10884521171749
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K162738
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number980
Device Catalogue Number980X1ENNISB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/07/2018
Initial Report FDA Received Date01/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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