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)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A service engineer (se) inspected the device and replaced the oxygen proportional solenoid (psol) valve to resolve 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.
Event or Problem Description
It was reported that during use while the registered nurse tried to suction the inline catheter, the 840 ventilator became inoperable.The ventilator had been turned off and on and was reported to still be inoperative.The patient was bagged and was transferred to an alternate ventilator.There was no harm to the patient as a result of the event.
Additional Manufacturer Narrative
Device evaluation summary: the following part was returned for failure investigation: pressure solenoid (psol).The psol was functionally tested and no malfunction or product deficiency was identified.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.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 7629977
• Report Number: 8020893-2018-00281
• Device Sequence Number: 2376208
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 08/08/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 08/01/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR