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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENT, INC. HT70 VENTIALTOR VENTILATOR, CONTINUOUS, FACILITY USE

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NEWPORT MEDICAL INSTRUMENT, INC. HT70 VENTIALTOR VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number HT70PM-JP-NA
Device Problem Defective Alarm (1014)
Patient Problem Insufficient Information (4580)
Event Type  Malfunction  
Manufacturer Narrative

Initial reporter from the facility could not be provided due to (b)(6) privacy regulation. Medtronic (b)(4) has received the suspect device/component from the customer for evaluation at the (b)(4) service center, but the device is yet to be evaluated by the service engineer. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the ht70 ventilator did not alarm when it was powered off. Although requested, it is unknown if a patient was c onnected to the ventilator at the time of the reported event.

 
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Brand NameHT70 VENTIALTOR
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
NEWPORT MEDICAL INSTRUMENT, INC.
1620 sunflower ave
costa mesa CA 92626
Manufacturer (Section G)
NEWPORT MEDICAL INSTRUMENT, INC.
1620 sunflower ave
costa mesa CA 92626
Manufacturer Contact
kelly adams
15 hampshire street
mansfield,ma, CA 02048
7606035046
MDR Report Key11400432
MDR Text Key241815564
Report Number2023050-2021-00008
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK111146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/02/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHT70PM-JP-NA
Device Catalogue NumberHT70PM-JP-NA
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/08/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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