MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND 740 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 740

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

The service engineer evaluated the ventilator and replaced the proportional solenoid (psol) printed circuit board (pcb).After serv icing, the ventilator passed all testing per manufacturer's specification and was returned to the customer.The psol pcb was visually inspected with no anomalies observed.The component was connected to a test ventilator.The fault was isolated to component u15.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the 700 series ventilator failed post (power on self test).The ventilator was not in use on a patient at the time of the reported event. .

• Brand Name: 740 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway,gw
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway,gw
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 8071957
• MDR Text Key: 127220656
• Report Number: 8020893-2018-00544
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 740
• Device Catalogue Number: G-740110DIUU-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1