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

Model Number	840
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 840 ventilator failed extended self-testing (est) due to a failed battery test.The ventilator was not in use on a patient at the time of the reported event.A covidien field service engineer (fse) inspected the device and replaced the back-up power source (bps) printed circuit board (pcb).The fse performed self-testing on the device and all tests passed.
Additional Manufacturer Narrative
A backup power source printed circuit boards (pcb) was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned component was performed, no notable conditions were found.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 no fault was found.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
An investigation was performed and the technician found that the reported problem could not be duplicated.No failure was detected.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: 6508826
• Report Number: 8020893-2017-05750
• Device Sequence Number: 1642010
• Product Code: CBK
• UDI-Device Identifier: 10884521077201
• UDI-Public: 10884521077201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 12/21/2017

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: 4-840220NISB-EN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: 06/08/2017; 06/08/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 10/17/2017; 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1