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 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 faulty battery.Patient involvement is unknown at this time.The service engineer inspected the device and replaced the bps, pcb, (backup power supply, printed circuit board).The service engineer ran an extended self test (est) and a short self test (sst) and unit passed all tests.
Additional Manufacturer Narrative
Evaluation codes,the backup power supply (bps) printed circuit board (pcb) was returned to medtronic¿s product analysis laboratory.A visual inspection was performed and it was found that the component was from a vendor.An investigation was performed and the reported issue could not be duplicated.No errors were recorded in the diagnostic logs during testing.No fault was found with the returned bps pcb.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.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6733570
• Report Number: 8020893-2017-07058
• Device Sequence Number: 13657272
• 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
• Report Date (Section B): 06/26/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1