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

Model Number	980
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during installation a 980 ventilator battery would not charge.The ventilator was not in use on a patient at the time of the reported event.The service engineer (se) inspected the device.The se replaced the power controller and power distribution board (pcb) and performed extended self-testing on the device and all tests passed.
Additional Manufacturer Narrative
Device evaluation: the returned breath delivery (bd) power distribution printed circuit board (pcb) was reported to have caused the ventilator battery not to charge.A visual inspection of the returned pcb was conducted and no anomalies were observed.The pcb was attached to the failure investigation test ventilator for analysis.The ventilator was powered up.The ventilator powered up normally.After reviewing the system diagnostic log it could be seen that a number of battery related error codes were generated.Also, it could be seen that the failure investigation battery was not charging.The fault was isolated to the r6 component on the pcb.The near open circuit defect on this r6 device would suggest that there was a power surge of some description which caused this damage.This type of power surge damage could potentially be caused by the inadvertent connection of a cable with the connector incorrectly orientated, or connection or disconnection of pcbs while the ventilator had ac or battery power connected.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: 6598929
• Report Number: 8020893-2017-06298
• Device Sequence Number: 13545363
• Product Code: CBK
• UDI-Device Identifier: 10884521171749
• UDI-Public: 10884521171749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131252
• 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): 03/16/2018

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: 03/14/2018
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1