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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
Device Problem Occlusion Within Device (1423)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
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 Description
It was reported that a 980 ventilator generated a severe occlusion.The ventilator was not in use on a patient at the time of the reported event.The service engineer (se) inspected the device and could not duplicate the reported event.The unit passed all testing and operated within the manufacturing specifications.
 
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Brand Name
980 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
Manufacturer (Section G)
COVIDIEN
micheal collins rd mervue
galway
Manufacturer Contact
ray maroofian
2101 faraday ave
carlsbad, CA 92008
7606035334
MDR Report Key6681211
MDR Text Key78828293
Report Number8020893-2017-06805
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131252
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2017
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
Device Operator Health Professional
Device Model Number980
Device Catalogue Number980
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2017
Initial Date Manufacturer Received 06/02/2017
Initial Date FDA Received06/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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