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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION APLIO XG TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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TOSHIBA MEDICAL SYSTEMS CORPORATION APLIO XG TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Device Problems Loss of Power (1475); Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 09/20/2017
Event Type  malfunction  
Event Description
Ultrasound machine went down; memory board down. Biomed assessed the issue and ordered parts. Part was supposed to arrive one afternoon so device was not available until the next morning.
 
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Brand NameAPLIO XG
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
TOSHIBA MEDICAL SYSTEMS CORPORATION
paul biggins
2441 michelle dr.
tustin CA 92780
MDR Report Key7013659
MDR Text Key91464011
Report Number7013659
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 09/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2017
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer09/29/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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