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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 980A3ENNISB
Medical Device Problem Code Improper Flow or Infusion (2954)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/04/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation summary: a third party biomedical engineer inspected the device and noted that the direct current (dc) to dc printed circuit board (pcb) had ¿burnt markings.¿ if the dc-dc pcba is returned for failure investigation, a supplemental 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 generated an alarm and entered ¿backup ventilation¿.The patient was removed from the ventilator and placed on an alternate ventilator 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
IE 
MDR Report Key10093955
Report Number8020893-2020-00082
Device Sequence Number3387490
Product Code CBK
UDI-Device Identifier10884521201910
UDI-Public10884521201910
Combination Product (Y/N)N
Initial Reporter CountryID
PMA/510(K) Number
K131252
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/27/2020
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 Number980A3ENNISB
Device Catalogue Number980A3ENNISB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/05/2020
Initial Report FDA Received Date05/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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