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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 740 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COVIDIEN 740 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 740
Medical Device Problem Code Device Inoperable (1663)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/14/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during use on a patient, the ventilator became inoperative and displayed a 'safety valve open' message.The patient was removed from the ventilator and placed on an alternate ventilator.There was no adverse event or consequences as a result.
 
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Brand Name
740 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
MDR Report Key7660481
Report Number8020893-2018-00297
Device Sequence Number2012083
Product Code CBK
UDI-Device Identifier10884521078369
UDI-Public10884521078369
Combination Product (Y/N)N
Initial Reporter StateND
Initial Reporter CountryUS
PMA/510(K) Number
K990897
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/03/2018
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 Number740
Device Catalogue NumberG-061792-00
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/15/2018
Initial Report FDA Received Date07/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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