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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENT, INC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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NEWPORT MEDICAL INSTRUMENT, INC HT70 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number HT70
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 05/19/2019
Type of Reportable Event Death
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for further evaluation.Upon receipt, an investigation will be performed, and the results will be submitted within a supplemental mdr.Facility where event occurred: (b)(6).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that a patient expired while on the ht70 ventilator.This event is being conservatively filed due to the reported death.At this time, there is no additional information available regarding the event or the ventilator.
 
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Brand Name
HT70 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
NEWPORT MEDICAL INSTRUMENT, INC
1620 sunflower ave
costa mesa CA 92626
MDR Report Key8786243
Report Number2023050-2019-00027
Device Sequence Number2338749
Product Code CBK
UDI-Device Identifier10884521542266
UDI-Public10884521542266
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K111146
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberHT70
Device Catalogue NumberHT70PM-WW-NA
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2019
Initial Report FDA Received Date07/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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