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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 Erratic or Intermittent Display (1182)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during installation/setup the ht70 ventilator screen froze at the six picture screen.There was no patient involvement at the time of the reported condition.The service engineer troubleshot the issue and recommended replacing the single board computer (sbc) board.
 
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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 Key6648956
Report Number2023050-2017-05484
Device Sequence Number815852
Product Code CBK
UDI-Device Identifier10884521542105
UDI-Public10884521542105
Combination Product (Y/N)N
Initial Reporter CountryCE
PMA/510(K) Number
K090888
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/06/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/06/2017
Initial Report FDA Received Date06/16/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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