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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSTA MESA MFG DC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COSTA MESA MFG DC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number E360E-JP-NA
Medical Device Problem Code No Flow (2991)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/11/2019
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 e360 ventilator had blank screen with audio alarm and stopped ventilation.It was also stated that the screen displayed normally when the device was turned off and turned on again.Patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.
 
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Brand Name
E360 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COSTA MESA MFG DC
1620 sunflower ave
costa mesa CA 92626
MDR Report Key9147516
Report Number2023050-2019-00044
Device Sequence Number16844748
Product Code CBK
UDI-Device Identifier10884521540941
UDI-Public10884521540941
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K101803
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/02/2019
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
Operator of Device Health Professional
Device Model NumberE360E-JP-NA
Device Catalogue NumberE360E-JP-NA
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2019
Initial Report FDA Received Date10/02/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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