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

Model Number	840
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for evaluation.The customer technician was to replace the graphical user interface (gui) printed circuit board (pcb) to resolve the reported issue.The ventilator is currently undergoing repairs and is not in use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use, the 840 ventilator shut down.The unit restarted but would not ventilate.The patient was removed and manually ventilated.A graphical user interface (gui) reset error code was provided.The patient was then transferred to an alternate ventilator and there was no harm or injury to the patient as a result of the event.The patient remained stable.
Additional Manufacturer Narrative
Additional information received as follows: all service activities were performed by the facilities onsite biomedical department.Once the graphical user interface was replaced, the ventilator was placed into normal ventilation mode and ran for several days with no recurrence of errors.The ventilator was placed back in clinical use.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: 7778386
• Report Number: 8020893-2018-00357
• Device Sequence Number: 11188894
• Product Code: CBK
• UDI-Device Identifier: 10884521076990
• UDI-Public: 10884521076990
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151252
• 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): 01/31/2019

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: 4-840220ASAA-EN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1