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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 10049980
Medical Device Problem Code Calibration Problem (2890)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/29/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during the testing, the o2 (oxygen) sensor on an 840 ventilator could not be calibrated.The ventilator was not in use on a patient at the time the event occurred.The service engineer (se) inspected the device and replaced the o2 sensor.The se performed extended self-testing on the device and all tests passed.
 
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Brand Name
840 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
MDR Report Key6752569
Report Number8020893-2017-07176
Device Sequence Number187655
Product Code CBK
UDI-Device Identifier10884521181250
UDI-Public10884521181250
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K970460
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) 06/30/2017
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 Number10049980
Device Catalogue Number10049980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2017
Initial Report FDA Received Date07/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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