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

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.

• Brand Name: APLIO XG
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; paul biggins; 2441 michelle dr.; tustin CA 92780
• MDR Report Key: 7013659
• MDR Text Key: 91464011
• Report Number: 7013659
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/09/2017
• 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 FDA: 09/29/2017
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/29/2017
• 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