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)
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 during patient use the 840 ventilator generated a high alarm, the screen went blank and ventilation stopped.The patient was manually ventilated via an ambu bag and placed on an alternate ventilator.There was no patient harm or injury as a result of the reported event.The customer's respiratory therapist evaluated the ventilator.Upon turning the ventilator on, the ventilator alarmed and message showed "needs service".
Additional Manufacturer Narrative
Correction to the aware date on initial mdr.The date should have been 2018 (b)(4).Correction to evaluation codes method, result and conclusion.Device evaluation summary: the field service engineer (fse) evaluated the ventilator and found that the ventilator logged error codes.The fse replaced the gui (graphic user interface) central processing unit (cpu) pcb (printed circuit board) and updated the required software associated with the gui pcu pcb.The ventilator passed all testing per manufacturer specifications and was returned to the customer for clinical use.If the replaced part is returned for failure investigation, a supplement medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the graphical user interface printed circuit board (xena ii) was returned for failure investigation.The part was visually inspected and functionally tested with no anomalies observed.Conclusion: 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: 7855391
• Report Number: 8020893-2018-00432
• Device Sequence Number: 16631796
• 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): 11/08/2018

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: 10/17/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/10/2018; 11/08/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 09/10/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 107