MAUDE Adverse Event Report: DYMAX, CORP. DYMAX SITE-RITE V; ULTRASOUND MACHINE

Model Number SITE-RITE V

Device Problems Poor Quality Image (1408); Failure to Transmit Record (1521)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The ultrasound that lives in room 7 once again would not record a picture for documentation of wires inserted in the internal jugular.The ultrasound has had numerous issues not the least of which is very poor picture quality.

• Brand Name: DYMAX SITE-RITE V
• Type of Device: ULTRASOUND MACHINE
• Manufacturer (Section D): DYMAX, CORP.; 141 zehner school rd.; zelienople PA 16063
• MDR Report Key: 6360126
• MDR Text Key: 68374648
• Report Number: 6360126
• Device Sequence Number: 1
• Product Code: IYO
• 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: Other
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: SITE-RITE V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR