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U.S. Department of Health and Human Services

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

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NELLCOR PURITAN BENNETT IRELAND 740 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
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.
 
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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 Key8758421
MDR Text Key149953984
Report Number8020893-2019-00129
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K990897
Number of Events Reported1
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 Number740
Device Catalogue NumberG-740220DIUR-EN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/10/2019
Initial Date FDA Received07/03/2019
Supplement Dates Manufacturer Received07/04/2019
Supplement Dates FDA Received07/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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