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 Type  malfunction  

Manufacturer Narrative

Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the 740 ventilator failed to alarm and found the device had check valve failure.The ventilator was not in use on a patient at the time of the reported event. .

Manufacturer Narrative

Device evaluation summary: the service personnel (sp) inspected the ventilator and replaced the pump outlet check valve.The ventilator passed all the tests, calibrations and has been returned to the customer.The cause of the observed conditions determined to be problem with the pump outlet check valve.The event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.

• 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: 8758421
• MDR Text Key: 149953984
• Report Number: 8020893-2019-00129
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K990897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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
• Device Operator: Health Professional
• Device Model Number: 740
• Device Catalogue Number: G-740220DIUR-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 07/04/2019
• Supplement Dates FDA Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2005
• 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