MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND 760 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	760
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer evaluated the ventilator and replaced the nvram (non volatile random access memory) also installed new oxygen cell as per preventive maintenance schedule.After servicing, the ventilator passed all testing per manufacturer's specification and was returned to the customer.The nvram was returned for failure investigation.The part was visually inspected with no anomalies observed.The component was connected to a test ventilator.The fault was isolated to electronic component.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the 700 series ventilator failed post (power on self test) with an error code.The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 760 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway,gw
• MDR Report Key: 8224677
• Report Number: 8020893-2019-00004
• Device Sequence Number: 18882647
• Product Code: CBK
• UDI-Device Identifier: 10884521180970
• UDI-Public: 10884521180970
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990897
• 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
• Report Date (Section B): 01/07/2019

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: 760
• Device Catalogue Number: G-061949-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1