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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 Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes No Patient Involvement (2645); No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the oxygen (o2) sensor of a 980 ventilator experienced a malfunction.Although requested, it is unknown if the patient was connected to the ventilator at the time of the reported event.The service engineer (se) replaced the o2 sensor.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that, during service, the oxygen (o2) sensor of a 980 ventilator experienced a malfunction.The ventilator was not in use on a patient at the time of the reported event.
 
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Brand Name
980 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway,ie
MDR Report Key6704505
Report Number8020893-2017-06901
Device Sequence Number16516871
Product Code CBK
UDI-Device Identifier10884521172593
UDI-Public10884521172593
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K131252
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/14/2017
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 Number980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2017
Initial Date Received by Manufacturer 06/09/2017
Supplement Date Received by Manufacturer11/13/2017
Initial Report FDA Received Date07/11/2017
Supplement Report FDA Received Date11/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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