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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 04/17/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation summary: the service engineer (se) inspected the device and replaced the universal serial bus (usb).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If the replaced part is returned for failure investigation, a supplement medwatch report with the findings will be submitted once the investigation is complete.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 entered into backup ventilation.The patient was removed from the ventilator and placed on an alternate ventilator.The patient desaturated.
 
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Brand Name
980 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
michael collins road mervue
galway
MDR Report Key7848546
Report Number8020893-2018-00421
Device Sequence Number11097283
Product Code CBK
UDI-Device Identifier10884521201224
UDI-Public10884521201224
Combination Product (Y/N)N
Initial Reporter CountryCO
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) 09/05/2018
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 Number980S1ESDIUA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/15/2018
Initial Report FDA Received Date09/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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