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 Code Available (3191)
Date of Event	03/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) verified the reported issue.The fse found error codes in the ventilator memory logs.The fse replaced the graphic user interface (gui) central processing unit (cpu) printed circuit board (pcb) and backlight inverter pcb¿s.The ventilator passed performance verification testing (pvt), electrical safety, extended self test (est), calibrations and short self test (sst) and was returned to the customer.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 shutdown with a breath delivery (bd) audio alarm and loss of graphic user interface (gui) light-emitting diode (led) alert.The patient was transferred to another ventilator and there was no harm to the patient as a result of the event.
Additional Manufacturer Narrative
Additional codes added to update evaluation codes method and result device evaluation summary: the graphical user interface (gui) printed circuit board, two (2) gui backlight assemblies and two (2) inverter harnesses were returned to medtronic for failure investigation.The gui backlight assemblies and inverter harnesses were visually inspected and functionally tested with no abnormalities observed.There was no malfunction or product deficiency identified.The gui pcb was visually inspected with no anomalies found.The part was attached to the failure investigation test ventilator for analysis.The ventilator was powered up.The ventilator powered up normally and no errors were recorded in the diagnostic logs.The ventilator was calibrated successfully.During est testing, the ventilator generated a gui inoperative condition.Further investigation isolated the fault to bga device, reference designator u102.The cause of the observed condition was determined to be electronic component failure u102.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: 7393994
• Report Number: 8020893-2018-00169
• Device Sequence Number: 13536532
• Product Code: CBK
• UDI-Device Identifier: 10884521076877
• UDI-Public: 10884521076877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 4-840120DICU-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1