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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 Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Patient Involvement (2645)
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 the oxygen (o2) sensor in a 980 ventilator would not calibrate and an alarm was generated.The ventilator was not in use on a patient at the time of the reported event.The service engineer (se) replaced the o2 sensor.The ventilator was calibrated.The unit passed all testing and operated within the manufacturing specifications.
 
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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 Key6754609
Report Number8020893-2017-07207
Device Sequence Number10800408
Product Code CBK
UDI-Device Identifier10884521172579
UDI-Public10884521172579
Combination Product (Y/N)N
Initial Reporter CountryGM
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) 07/04/2017
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 Manufacturer07/04/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/04/2017
Initial Report FDA Received Date07/31/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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