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

Model Number	840
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer attempted to do self-testing on the ventilator but when the unit was turned on, the unit had a "safety valve open unable to ventilate, do not use on patient" message.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.Should the replaced component be returned to the manufacturing site, an additional evaluation will be performed and a supplemental report will be submitted.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 a system failure and a "not ventilated patient" alarm.The unit had generated several error codes which rendered the unit inoperative.The patient was placed on an alternate ventilator without harm or injury.
Additional Manufacturer Narrative
Device evaluation summary: the proportional solenoid was returned for failure investigation.The part was visually inspected and functionally tested with no anomalies observed.Conclusion: there was no fault found.There was no malfunction or product deficiency identified.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: 8341737
• Report Number: 8020893-2019-00030
• Device Sequence Number: 1788978
• 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
• Report Date (Section B): 02/25/2019

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: 02/20/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1