MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) inspected the device and found a fault located in the breath delivery (bd) power control/distribution assembly.The fse replaced the bd power control/distribution assembly.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, during preventative maintenance, a 980 ventilator failed the breath delivery (bd) audio test on an extended self test (est).The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Device evaluation: the breath delivery (bd) power distribution printed circuit board (pcb) and the bd power controller pcb were returned for failure investigation.Both components were visually inspected with no anomalies observed.The bd power distribution pcb was functionally tested with no alarms or errors during the minimum 24 hours of run time.Conclusion: no fault found the bd power controller pcb was attached to the failure investigation test ventilator for analysis.The ventilator powered up but failed the "bd audio test" during the extended self test (est).The fault was isolated to a capacitor, reference designator c4 on the bd power controller pcb.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 7270453
• Report Number: 8020893-2018-00086
• Device Sequence Number: 2006407
• Product Code: CBK
• UDI-Device Identifier: 10884521201385
• UDI-Public: 10884521201385
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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 Number: 980
• Device Catalogue Number: 980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1