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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 Device Displays Incorrect Message (2591)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
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 that, a 980 ventilator generated a communication error message.Although requested, it is unknown if the patient was connected to the ventilator at the time of the event.The service engineer (se) inspected the device.The se replaced the memory card and performed extended self-testing on the device and all tests passed.
 
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Brand Name
980 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
MDR Report Key6661296
Report Number8020893-2017-06687
Device Sequence Number211122
Product Code CBK
UDI-Device Identifier10884521171619
UDI-Public10884521171619
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K131252
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) 05/29/2017
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 Number980
Device Catalogue Number980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2017
Initial Report FDA Received Date06/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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