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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 Output Problem (3005)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 02/25/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation summary: service personnel (sp) inspected the ventilator, found a burnt capacitor c83 on direct current (dc)-dc converter printed circuit board (pcb) and replaced the component.The ventilator passed all required testing per manufacturer's specifications at the time of service and product is in working condition.The dc-dc converter pcb was returned to medtronic for further analysis.A visual inspection of the returned part was conducted and it was observed that component c83 had thermal damage.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that a 980 ventilator had a powering on issue.The ventilator was not in use on a patient at the time of the reported event.
 
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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 Key8604699
Report Number8020893-2019-00107
Device Sequence Number16724229
Product Code CBK
UDI-Device Identifier10884521201507
UDI-Public10884521201507
Combination Product (Y/N)N
Initial Reporter CountryNZ
PMA/510(K) Number
K162738
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/13/2019
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 Number980U3ENASAA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/26/2019
Initial Report FDA Received Date05/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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