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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 980
Medical Device Problem Code Defective Alarm (1014)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: the service engineer (se) inspected the device and verified the reported issue.The se updated the software to the current revision.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that a 980 ventilator buttons did not work and the alarm did not sound.The ventilator was not in use on a patient at the time of the reported event.
 
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Brand Name
980 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
michael collins road mervue
galway
MDR Report Key7848694
Report Number8020893-2018-00427
Device Sequence Number19216207
Product Code CBK
UDI-Device Identifier10884521171619
UDI-Public10884521171619
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K162738
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/05/2018
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 Number980
Device Catalogue Number980X1PLDIPC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/23/2018
Initial Report FDA Received Date09/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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