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

Model Number	840
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Type of Reportable Event	Serious Injury
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 stopped during ventilation.The ventilator generated a gui inoperable error.The technician inspected the device and performed an extended self test (est).The ventilator passed the est.Unit is not in use as the technician wishes to discuss error log with manufacturer.Although requested, information pertaining to the patient outcome has not been provided.No further information is available at this time.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that the patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.The service engineer inspected the device and replaced the graphic user interface printed circuit board (pcb) to address the issue.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6590381
• Report Number: 8020893-2017-06249
• Device Sequence Number: 13534145
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/08/2017
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention