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

Model Number	840
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported an 840 ventilator had a frozen/locked screen.Although requested it is unknown if the patient was connected to the ventilator at the time of the reported event.The service engineer replaced the touch frame/display.The service engineer performed testing and calibrations and the unit operated within the manufacturer's specifications.
Additional Manufacturer Narrative
Product analysis: a touch frame printed circuit board (pcb) was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned component was performed and areas of contamination were found on the pcb.The contamination was found to be as a result of fluid ingress originating from cleaning products.The returned component was installed into a test ventilator for analysis; no errors were recorded in the diagnostic logs.An investigation was performed and the product analysis technician reported that the root cause was isolated to the contamination.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
There was no patient involvement at the time of the event.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6818126
• Report Number: 8020893-2017-07597
• Device Sequence Number: 129890
• Product Code: CBK
• UDI-Device Identifier: 10884521077058
• UDI-Public: 10884521077058
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 12/06/2017

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: 4-840220DIEC-SP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1