MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 6 SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9770066

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Per biomed: the scanner has artifacts on screen.

Event Description

Per biomed: the scanner has artifacts on screen.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image with artifacts could not be reproduced during evaluation.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed no other similar complaint(s) from this serial number.

• Brand Name: SITE-RITE 6 SCANNER
• 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: 8057528
• MDR Text Key: 126951991
• Report Number: 3006260740-2018-03204
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741091049
• UDI-Public: (01)00801741091049
• Combination Product (y/n): N
• PMA/PMN Number: K071204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770066
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1