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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 Device Alarm System (1012)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/22/2017
Type of Reportable Event Serious Injury
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 while in use on a patient an 840 ventilator was generating an alarm intermittently and showing high ratio alarm limits.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of this event.The service engineer was unable to duplicate the reported condition.Service engineer ran calibrations, extended self test (est), short self test (sst), performance verification test (pvt) and electrical safety test and device passed all testing.
 
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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 Key6732079
Report Number8020893-2017-07053
Device Sequence Number13666978
Product Code CBK
UDI-Device Identifier10884521077201
UDI-Public10884521077201
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 06/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number840
Device Catalogue Number4-840220NISB-EN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2017
Initial Report FDA Received Date07/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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