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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS INC. HT70 PLUS; VENTILATOR, CONTINUOUS, FACILITY USE
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NEWPORT MEDICAL INSTRUMENTS INC. HT70 PLUS; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number HT70P
Medical Device Problem Code Battery Problem (2885)
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 had a bad battery.Patient involvement information was not provided by the customer.The service engineer (se) replaced the coin cell battery.The ventilator was tested and checked to be running normally.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The ventilator was not in use on a patient at the time of the reported event.
 
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Brand Name
HT70 PLUS
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
NEWPORT MEDICAL INSTRUMENTS INC.
1620 sunflower ave
costa mesa CA 92626
MDR Report Key6619858
Report Number2023050-2017-05422
Device Sequence Number18956319
Product Code CBK
UDI-Device Identifier10884521542228
UDI-Public10884521542228
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K111146
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/04/2017
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 NumberHT70P
Device Catalogue NumberHT70PM-SY-EU
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/23/2017
Supplement Date Received by Manufacturer12/01/2017
Initial Report FDA Received Date06/07/2017
Supplement Report FDA Received Date12/04/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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