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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 Patient Involvement (2645)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a 980 ventilator generated a serial mismatch error code.The ventilator was not on a patient at the time of the reported event.
 
Event or Problem Description
The service engineer (se) inspected the device.The se replaced the universal serial bus (usb) flash drive.The se 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 Key6586126
Report Number8020893-2017-06213
Device Sequence Number613706
Product Code CBK
UDI-Device Identifier10884521201385
UDI-Public10884521201385
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K131252
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) 04/26/2017
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 Manufacturer05/23/2017
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 04/26/2017
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date05/23/2017
Supplement Report FDA Received Date06/02/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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