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

Model Number	840
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an 840 ventilator failed post (power on self test).The ventilator was not on a patient at the time of the event.The evaluation and repair of the device has not been completed.
Additional Manufacturer Narrative
The service engineer (se) verified the event and found the o2 flow sensor connector was loose.Connections have been strengthened and the unit passed all testing and operated within the manufacturer specifications.
Event or Problem Description
The evaluation and repair of the device has been completed.
Additional Manufacturer Narrative
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: 6606254
• Report Number: 8020893-2017-06350
• Device Sequence Number: 13609912
• Product Code: CBK
• UDI-Device Identifier: 10884521077065
• UDI-Public: 10884521077065
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Followup
• Report Date (Section B): 05/10/2017

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: 840
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 05/10/2017; 05/10/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 08/28/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1