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

Model Number	840
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/13/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An inspiratory flow sensor was replaced.Product analysis: an inspiratory flow sensor was returned to covidien/ medtronic¿s product analysis.A visual inspection was performed and found contamination on the hot film element and also on the circular plastic disc attached to the flow sensor printed circuit board (pcb).The returned component was installed into a test ventilator for analysis; no errors were recorded in the diagnostic logs and functionality testing was performed.An investigation was performed and the product analysis technician reported that the root cause was isolated to the contamination of the hot film element.The event was originally submitted through the remedial act e2017032 on 2017-07-31.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the preventative maintenance service, the 840 ventilator failed the flow sensor calibration.There was no patient involvement.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 7267938
• Report Number: 8020893-2018-00082
• Device Sequence Number: 13932643
• Product Code: CBK
• UDI-Device Identifier: 10884521077096
• UDI-Public: 10884521077096
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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: 4-840220DIPC-PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1