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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 Leak/Splash (1354)
Health Effect - Clinical Code No Information (3190)
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 a ht70 ventilator had an oxygen mixer leak.The customer did not provide patient involvement information.A medtronic field service engineer (fse) evaluated the ventilator and confirmed the customer reported issue.It was determined that the oxygen mixer needs to be replaced.
 
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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 Key6555033
Report Number2023050-2017-05276
Device Sequence Number18989420
Product Code CBK
UDI-Device Identifier10884521542228
UDI-Public10884521542228
Combination Product (Y/N)N
Initial Reporter CountryPL
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) 04/13/2017
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 NumberHT70PM-SY-EU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/13/2017
Initial Report FDA Received Date05/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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