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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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NEWPORT MEDICAL INSTRUMENTS, INC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number HT70
Medical Device Problem Code Failure to Power Up (1476)
Health Effect - Clinical Codes No Patient Involvement (2645); No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the ht70 ventilator screen was not booting up completely, patient involvement is unknown.A non covidien/ medtronic service inspected the device and found that the single board computer was defective.Covidien/ medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Additional information was received that the reported issue occurred during maintenance.There was no patient involvement at the time of the event.
 
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Brand Name
HT70 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
NEWPORT MEDICAL INSTRUMENTS, INC
1620 sunflower ave
costa mesa CA 92626
MDR Report Key6501089
Report Number2023050-2017-05177
Device Sequence Number16338984
Product Code CBK
UDI-Device Identifier10884521542105
UDI-Public10884521542105
Combination Product (Y/N)N
Initial Reporter CountryTH
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,Followup
Report Date (Section B) 10/25/2017
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-SY-EU
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/21/2017
Supplement Date Received by Manufacturer04/20/2017
Initial Report FDA Received Date04/18/2017
Supplement Report FDA Received Date10/25/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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