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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 Device Inoperable (1663)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/08/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The field service engineer evaluated the ventilator and found a relevant code in the ventilator memory.The external battery was replaced.The ventilator passed all testing and was placed back in clinical use.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.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
760 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
MDR Report Key7659563
Report Number8020893-2018-00296
Device Sequence Number2364885
Product Code CBK
UDI-Device Identifier10884521180970
UDI-Public10884521180970
Combination Product (Y/N)N
Initial Reporter StateSC
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 Number760
Device Catalogue NumberG-061949-00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2018
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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