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 Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, while in use on a patient, the 840 ventilator generated an alarm and generated error codes indicating post (power on self test) failure and oxygen psol (proportional solenoid) valve stuck open and rendering the ventilator to become inoperative.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.
Additional Manufacturer Narrative
Received additional information on 2018-jul-05 that the correct ventilator serial number was (b)(4).This event was previously reported under mfr report # 8020893-2018-00281.Please reference mfr report # 8020893-2018-00281 for all information regarding this event.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: 7656699
• Report Number: 8020893-2018-00288
• Device Sequence Number: 1512081
• Product Code: CBK
• UDI-Device Identifier: 10884521076877
• UDI-Public: 10884521076877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/05/2018

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: 4-840120DICU-EN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1