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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
Medical Device Problem Code Battery Problem (2885)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a ht70 plus ventilator had a coin battery failure and a possible external battery issue.The ventilator was not in use on a patient at the time of the reported event.
 
Additional Manufacturer Narrative
The service engineer (se) inspected the device, replaced the coin battery and found no issue with the external battery.The se performed calibrations and extended self-testing on the device and all tests passed.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 Key6819130
Report Number2023050-2017-05771
Device Sequence Number18864462
Product Code CBK
UDI-Device Identifier10884521542235
UDI-Public10884521542235
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K111146
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/26/2017
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 NumberHT70
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2017
Initial Date Received by Manufacturer 07/26/2017
Supplement Date Received by Manufacturer07/26/2017
Initial Report FDA Received Date08/24/2017
Supplement Report FDA Received Date10/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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