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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 840
Medical Device Problem Code No Flow (2991)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/08/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The customer evaluated the 840 ventilator and replaced the exhalation sensor.The ventilator passed all testing per manufacturer specifications.If the replaced part is returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported during use the 840 ventilator stopped ventilating and generated a device alert " no ventilation safety valve open".The patient was not harmed or injured as a result of the reported event.
 
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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 Key8674424
Report Number8020893-2019-00120
Device Sequence Number19426344
Product Code CBK
UDI-Device Identifier10884521076990
UDI-Public10884521076990
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K151252
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/06/2019
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 Number840
Device Catalogue Number4-840220ASAA-EN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/15/2019
Initial Report FDA Received Date06/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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