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

Model Number	4-840220AIQC-FR
Medical Device Problem Codes	No Flow (2991); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during preventative maintenance, this 840 ventilator generated a visual and sound alarm with a background checks gui (graphical user interface) diagnostic code.It was additionally reported that continuous audible alarm, ¿technical alarm¿, visual message ¿vent inop¿, and post bdu (power on self test, breath delivery unit) diagnostic code were generated.The device was available for evaluation.The medtronic field service engineer (fse) evaluated the ventilator and replaced the breath delivery unit central processing unit printed circuit board (bd cpu pcb) and analog interface (ai) printed circuit board assembly (pcba).The ventilator passed all testing per manufacturer specification at the time of service.The bd cpu pcb was returned to medtronic but was unable to be tested as this was an obsolete part.The analog interface printed circuit board (ai pcb) was returned for further analysis: a visual inspection was carried out on the returned component, no anomalies were observed.The component was attached to the failure investigation test ventilator for analysis and powered up but failed the flow sensor cross check test.The fault was isolated to component reference designator u31.The likely cause of the reported event was isolated to the analog interface printed circuit board (ai pcb).The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during preventative maintenance, this 840 ventilator generated a visual and sound alarm with a background checks gui (graphical user interface) diagnostic code.It was additionally reported that continuous audible alarm, ¿technical alarm¿, visual message ¿vent inop¿, and post bdu (power on self test, breath delivery unit) diagnostic code were generated.The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 13238889
• Report Number: 8020893-2022-00004
• Device Sequence Number: 4610402
• Product Code: CBK
• UDI-Device Identifier: 10884521076983
• UDI-Public: 10884521076983
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2022

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: 4-840220AIQC-FR
• Device Catalogue Number: 4-840220AIQC-FR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown