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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
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 that an 840 ventilator had a communications error generated.The ventilator was replaced.There was no injury reported, ventilation did not stop.The evaluation and repair of the device has not been completed.
Additional Manufacturer Narrative
Correction: (b)(4) 2017.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A breath delivery printed circuit board (pcb) was returned to covidien/medtronic¿s failure analysis.A visual inspection found no table conditions.An investigation was performed and the identified root cause of the reported issue could not be duplicated.
Additional Manufacturer Narrative
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: 6588620
• Report Number: 8020893-2017-06231
• Device Sequence Number: 10954363
• Product Code: CBK
• UDI-Device Identifier: 10884521076990
• UDI-Public: 10884521076990
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 840
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 08/17/2017; 08/17/2017; 07/18/2017; 07/18/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 08/14/2017; 08/14/2017; 10/04/2017; 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention