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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 Improper Flow or Infusion (2954)
Health Effect - Clinical Code Low Oxygen Saturation (2477)
Date of Event 05/22/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: the service engineer (se) inspected the device, reviewed the logs and found relevant codes related to the reported issue but was unable to duplicate it.The se performed calibrations and extended self-testing on the device and all tests passed.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that, while in use on a patient, a 980 ventilator alarmed with the message: no oxygen delivery and entered back up ventilation.The patient was removed from the ventilator and manually ventilated via an ambu bag before being placed on an alternate ventilator.The patient de-saturated and then recovered with no harm or injury.
 
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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 Key8678354
Report Number8020893-2019-00121
Device Sequence Number19253615
Product Code CBK
UDI-Device Identifier10884521171749
UDI-Public10884521171749
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 06/07/2019
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 Number980X1ENNISB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/22/2019
Initial Report FDA Received Date06/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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