MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9760107

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the screen displayed unclear images.

• Brand Name: SITE~RITE 5 ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9988861
• MDR Text Key: 195128778
• Report Number: 3006260740-2020-01486
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K052517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 9760107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse