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

Model Number	840
Medical Device Problem Codes	No Flow (2991); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, medtronic has not received the suspect device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient, the 840 ventilator stopped ventilation and the systems locked out.There was no injury to the patient as a result of the event.
Additional Manufacturer Narrative
Device evaluation: it was reported that the unit passed self-testing.The unit however, was noted to not have yet been returned to use.Information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was placed on an alternate ventilator and there was no injury to the patient as a result 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: 7912672
• Report Number: 8020893-2018-00472
• Device Sequence Number: 2052385
• Product Code: CBK
• UDI-Device Identifier: 10884521076976
• UDI-Public: 10884521076976
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

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: 4-840220AIQC-EN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1