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

Model Number	840
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use, the 840 ventilator generated a device alert and stopped working.The patient's oxygen saturation dropped from 94% to 86%.At this time, it is unknown if the patient was transferred or the patient outcome.
Additional Manufacturer Narrative
Correction: pma/510 (k), additional information: unique identifier (udi) #.On 2018-may-04, additional information regarding the repairs was received.Evaluation summary: a service engineer (se) inspected the device and was unable to duplicate the reported issue.The unit passed testing and operated within the manufacturing specifications.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: 7266849
• Report Number: 8020893-2018-00081
• Device Sequence Number: 11261190
• Product Code: CBK
• UDI-Device Identifier: 10884521077201
• UDI-Public: 10884521077201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151252
• 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): 05/07/2018

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: 01/04/2018
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1