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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSTA MESA MFG DC NEWPORT MEDICAL INSTRUMENTS, INC.; VENTILATOR, CONTINUOUS, FACILITY USE
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COSTA MESA MFG DC NEWPORT MEDICAL INSTRUMENTS, INC.; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number HT70
Medical Device Problem Code Battery Problem (2885)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/05/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a ht70 ventilator generated a replace backup battery alarm.There was no report of patient harm or injury.The ventilator was evaluated by a third party service engineer and the customer reported issue was confirmed.To resolve the issue, the control board was replaced.The ventilator works normally.Repair was completed at a non-medtronic location and the product is not in medtronic control.The reported complaint could not be confirmed without the product return.
 
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Brand Name
NEWPORT MEDICAL INSTRUMENTS, INC.
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COSTA MESA MFG DC
1620 sunflower ave
costa mesa CA 92626
MDR Report Key6573497
Report Number2023050-2017-05296
Device Sequence Number13800712
Product Code CBK
UDI-Device Identifier10884521542044
UDI-Public10884521542044
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K090888
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/05/2017
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 NumberHT70
Device Catalogue NumberHT70M-CN-NA
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2017
Initial Report FDA Received Date05/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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