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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 Device Inoperable (1663)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/27/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) reviewed data logs and found back up ventilation error codes that coincided with the ventilator inoperative alarm.The fse replaced the universal serial bus (usb).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 generated a ¿ventilator inoperative¿ alarm.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result 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 Key7489056
Report Number8020893-2018-00208
Device Sequence Number11256852
Product Code CBK
UDI-Device Identifier10884521201248
UDI-Public10884521201248
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
K162738
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
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 Number980S1ESDIUU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2018
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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