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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.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 screen was "flickering" and the ventilator stopped ventilation.The patient was not harmed or injured as a result of the reported event.
Additional Manufacturer Narrative
Device evaluation summary: the service engineer inspected the device and replaced the graphical user interface (gui) central processing unit (cpu) and upgraded the backlight inverter printed circuit boards (pcb¿s).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.Per the field service findings and parts replaced on the ventilator, there is no indication that there was a loss of ventilation to the patient.If the gui fails while in use on a patient, the ventilator will continue to deliver breaths at the existing settings.If the replaced parts are returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.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: 7929740
• Report Number: 8020893-2018-00488
• Device Sequence Number: 2305565
• Product Code: CBK
• UDI-Device Identifier: 10884521077201
• UDI-Public: 10884521077201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840220NISB-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1