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

Model Number	840
Medical Device Problem Codes	Device Inoperable (1663); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, covidien/medtronic has not received the suspect device/component from the customer for evaluation.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 ventilator generated error codes which rendered the ventilator in an inoperable condition and breath delivery (bd) power on self-test (post) failure.The ventilator was not in use on a patient at the time the event occurred.The service engineer (se) replaced the breath delivery unit (bdu) printed circuit board (pcb) and upgraded the software to the latest version.The unit passed all testing and operated within the manufacturer specifications.In the event, the device is received for evaluation or additional information is received a follow-up report will be submitted.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6750901
• Report Number: 8020893-2017-07156
• Device Sequence Number: 821225
• Product Code: CBK
• UDI-Device Identifier: 10884521077096
• UDI-Public: 10884521077096
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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: 4-840220DIPC-PL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1