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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALPINION MEDICAL SYSTEM CO., LTD. ULTRASONOGRAPHY MACHINE, ECUBE 7 SYSTEM, IMAGING PULSED ECHO ULTRASONIC

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ALPINION MEDICAL SYSTEM CO., LTD. ULTRASONOGRAPHY MACHINE, ECUBE 7 SYSTEM, IMAGING PULSED ECHO ULTRASONIC Back to Search Results
Model Number ECUBE-7
Device Problems Defective Component (2292); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2016
Event Type  malfunction  
Event Description
Subject-regarding ultrasound machine which has defect in running application since installation; respected sir/madam, myself from (b)(6) clinic purchased ultrasound machine 2 years back (ecube 7) which company say that it's fda approved, i would like to pay your attention that 1 application is not working in this model. There is no satisfactory answer as well as solution for the alpinion company since more than 2 year. Problem is with echocardiography - tdi (tissue doppler imaging) which has 2 parts. (1) pw-tdi, (2) color-tdi. Both helps in diagnosis. Second part which is color tdi is not working in above said model. When asked about this problem to the concerned company people they did not give any solution or satisfactory answer for this problem. It's almost been 2 year but no solution till now. Once if it's approved by fda then company should provide application which should be working. Hope you will look into the matter and solve it soon. Detail of company below company name - (b)(6).
 
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Brand NameULTRASONOGRAPHY MACHINE, ECUBE 7
Type of DeviceSYSTEM, IMAGING PULSED ECHO ULTRASONIC
Manufacturer (Section D)
ALPINION MEDICAL SYSTEM CO., LTD.
seoul 15284 8
KS 152848
MDR Report Key7757418
MDR Text Key116536946
Report NumberMW5078904
Device Sequence Number0
Product Code IYO
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberECUBE-7
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/06/2018 Patient Sequence Number: 1
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