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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC HT70 VENTILATOR; CONTINUOUS VENTILATOR
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NEWPORT MEDICAL INSTRUMENTS, INC HT70 VENTILATOR; CONTINUOUS VENTILATOR Back to Search Results
Model Number HT70
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Patient Involvement (2645)
Event Date 01/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A non-covidien service provider replaced the single board computer (sbc) and the problem was resolved.Covidien was not authorized to evaluate/service the device so the reported complaint could not be confirmed.
 
Event Description
It was reported that at a time of maintenance the ht70 ventilator screen froze during power on.There was no patient involvement.
 
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Brand Name
HT70 VENTILATOR
Type of Device
CONTINUOUS VENTILATOR
Manufacturer (Section D)
NEWPORT MEDICAL INSTRUMENTS, INC
1620 sunflower ave.
costa mesa CA 92626
Manufacturer (Section G)
NEWPORT MEDICAL INSTRUMENTS, INC
1620 sunflower ave.
costa mesa CA 92626
Manufacturer Contact
ray maroofian
2101 faraday ave
carlsbad, CA 92008
7606035334
MDR Report Key6347923
MDR Text Key68216626
Report Number2023050-2017-00161
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K090888
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 01/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHT70
Device Catalogue NumberHT70M-JP-NA
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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