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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN ORANGEMED, INC. NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM VENTILATOR, CONTINUOUS, FACILITY USE

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NIHON KOHDEN ORANGEMED, INC. NIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number NKV-550-U
Device Problem No Display/Image (1183)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 08/14/2020
Event Type  Malfunction  
Manufacturer Narrative

Device has not been returned for evaluation yet. A supplemental report will be issued if additional information is obtained. Patient diagnosis is pulmonary hypertension.

 
Event Description

It was reported that during patient use, the graphic user interface display screen froze. The breath delivery unit continued to ventilate patient as designed. No patient harm was noted.

 
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Brand NameNIHON KOHDEN NKV-550 SERIES VENTILATOR SYSTEM
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
NIHON KOHDEN ORANGEMED, INC.
1800 e. wilshire ave.
santa ana CA 92705
Manufacturer (Section G)
NIHON KOHEN ORANGEMED, INC.
1800 e. wilshire ave.
santa ana CA 92705
Manufacturer Contact
sheryl higgins
1800 e. wilshire ave.
santa ana, CA 92705
949502644
MDR Report Key10521964
MDR Text Key218975119
Report Number3014631252-2020-00003
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK181695
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/01/2005,09/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNKV-550-U
Device Catalogue NumberNKV-550-U
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/23/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received08/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/29/2020
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/11/2020 Patient Sequence Number: 1
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