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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)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) evaluated the ventilator evaluated the ventilator and found an error code related to an air filter switch open.The fse calibrated the ventilator and tested the ventilator which passed all testing.The ventilator was returned to the customer for 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 760 ventilator stopped ventilation to the patient.Patient was removed from the ventilator and placed on an alternate ventilator with no harm 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
MDR Report Key7580872
Report Number8020893-2018-00261
Device Sequence Number11144079
Product Code CBK
UDI-Device Identifier10884521180970
UDI-Public10884521180970
Combination Product (Y/N)N
Initial Reporter StateNJ
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) 06/07/2018
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 Manufacturer05/29/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/23/2018
Initial Report FDA Received Date06/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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