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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 Audible Alarm (1019)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/26/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The service engineer (se) inspected the device and verified the reported issue.The se replaced the power control/distribution assembly.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 a 980 ventilator failed the breath delivery (bd) audio test on an extended self test (est).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
michael collins road mervue
galway
MDR Report Key7489064
Report Number8020893-2018-00210
Device Sequence Number1963348
Product Code CBK
UDI-Device Identifier10884521201552
UDI-Public10884521201552
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K162738
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/04/2018
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 Number980U3PTDIUNA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/26/2018
Initial Report FDA Received Date05/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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