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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 10/29/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A service engineer (se) inspected the device and found associated error codes in the unit's memory; however, the customer did not want the unit repaired.The device was scrapped.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, the 840 ventilator generated a red alarm and stopped delivering breaths to the patient.The patient was placed on an alternate ventilator without harm.
 
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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 Key8634572
Report Number8020893-2019-00115
Device Sequence Number11173739
Product Code CBK
UDI-Device Identifier10884521077188
UDI-Public10884521077188
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K151252
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
Report Date (Section B) 05/22/2019
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 Number4-840220DRAC-GR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2019
Initial Report FDA Received Date05/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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