MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND 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
Device evaluation the field service engineer (fse) evaluated the ventilator and found communications and unexpected hardware signal.The fse found fluid traces in the gui (graphic user interface).The fse removed the fluid traces and replaced gui (graphic user interface) pcb (printed circuit board) to resolve the issue.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 pb840 ventilator experienced an audible and visual alarm and stopped ventilation.The ventilator generated an error code in the memory indicating an unexpected hardware signal.According to the ventilator logs, gui (graphic user interface) central processing unit (cpu) software stopped communicating with the bd (breath delivery) an error code was logged.The condition persisted causing a gui (graphic user interface) post (power on self test) to fail.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.This event is being conservatively reported as the field service engineer reported that there was a loss of ventilation during the event; however, there is no evidence from the codes reported, service manual documentation on the code or the repair performed that ventilator would have stopped ventilation during this event.
Additional Manufacturer Narrative
The graphical user interface printed circuit board (xena ii gui pcb) 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): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• MDR Report Key: 7656867
• Report Number: 8020893-2018-00290
• Device Sequence Number: 11150487
• Product Code: CBK
• UDI-Device Identifier: 10884521077188
• UDI-Public: 10884521077188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/17/2018

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: 4-840220DRAC-GR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1