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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 760 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COVIDIEN 760 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 760
Medical Device Problem Code No Flow (2991)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/18/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The customer recharged the battery.The ventilator passed the battery load test after charging.The device is continuously being used.No patient harm was reported.There was no parts replaced.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during use on patient the 700 series ventilator sudden shutdown.Manual ventilation was performed.There was only one device the customer could use so the technician recharged the battery.The ventilator passed the battery load test after charging.The device is continuously being used.No patient harm was reported.
 
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Brand Name
760 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway,gw
MDR Report Key7778999
Report Number8020893-2018-00359
Device Sequence Number19133707
Product Code CBK
UDI-Device Identifier10884521180918
UDI-Public10884521180918
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K990897
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/13/2018
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 Number760
Device Catalogue NumberG-760110DIUU-JP
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/20/2018
Initial Report FDA Received Date08/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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