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

Model Number	840
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2017
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, an 840 vent was functioning on alternating current (ac).The ventilator was not in use on a patient at the time the event occurred.The covidien service engineer (se) verified the issue and replaced the power supply.The unit passed all testing and operated within the manufacturing specifications.
Additional Manufacturer Narrative
A condor power supply was returned to covidien/medtronic¿s product analysis.A visual inspection found two corners of the metal chassis were damaged.An investigation was performed and the product analysis technician reported that the reported issue was isolated to an electronic component failure in the power supply.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6747547
• Report Number: 8020893-2017-07135
• Device Sequence Number: 10968144
• Product Code: CBK
• UDI-Device Identifier: 10884521077034
• UDI-Public: 10884521077034
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

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: 4-840220DIEC-IT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1