MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	840
Medical Device Problem Code	Failure To Run On AC/DC (1001)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the field service engineer evaluated the ventilator and replaced the power supply.The ventilator passed all tests and calibrations; operates within medtronic specifications upon completion of service.The tamura (taiyo yuden) power supply was returned for failure investigation.A visual inspection of the returned part was conducted and no anomalies were observed.The part was attached to the failure investigation test ventilator for analysis.The ventilator was powered up bit failed at the power up stage with error codes.The fault was isolated to the v3 (+15v) and v4 (-15v) rails to the bdu breath delivery unit.The voltage rails were out of specification, reading approximately +6v and +0.6v respectively, when they should have been reading +15v and -15v respectively.All other voltage rails were reading within specification.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that an 840 ventilator generated ventilator inoperable error codes.The ventilator was not in use on a patient at the time of the event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 7664899
• Report Number: 8020893-2018-00302
• Device Sequence Number: 2514876
• Product Code: CBK
• UDI-Device Identifier: 10884521077188
• UDI-Public: 10884521077188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151252
• 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
• Report Date (Section B): 07/05/2018

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 Number: 840
• Device Catalogue Number: 4-840220DRAC-GR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1