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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 Codes Device Inoperable (1663); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 10/23/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the 840 ventilator had shut down without any 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.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Additional information was received that the ventilator had a reset and continued to ventilate the patient.
 
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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 Key7000720
Report Number8020893-2017-07768
Device Sequence Number1850978
Product Code CBK
UDI-Device Identifier10884521077058
UDI-Public10884521077058
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K970460
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/14/2017
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 Number840
Device Catalogue Number4-840220DIEC-SP
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/24/2017
Supplement Date Received by Manufacturer11/10/2017
Initial Report FDA Received Date11/03/2017
Supplement Report FDA Received Date11/14/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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