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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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NEWPORT MEDICAL INSTRUMENTS, INC HT70 PLUS VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number HT70 PLUS
Medical Device Problem Code No Display/Image (1183)
Health Effect - Clinical Code No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the ht70 plus ventilator touch screen was not working.Patient involvement is unknown.
 
Additional Manufacturer Narrative
Additional information was received that a service provider inspected the device and found that the key pads are not working.The service provider will replace the key pads.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
HT70 PLUS VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
NEWPORT MEDICAL INSTRUMENTS, INC
1620 sunflower ave
costa mesa CA 92626
MDR Report Key6449826
Report Number2023050-2017-05113
Device Sequence Number16488477
Product Code CBK
UDI-Device Identifier10884521542228
UDI-Public10884521542228
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K111146
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/09/2018
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 PLUS
Device Catalogue NumberHT70PM-SY-EU
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/06/2017
Supplement Date Received by Manufacturer06/02/2017
Initial Report FDA Received Date03/31/2017
Supplement Report FDA Received Date02/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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