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

Catalog Number 9770066

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Device has not been returned, at this time.

Event Description

Biomed reported the system has poor image quality in dark mode.The screen is reported to go blank, however, in dim mode, the screen is reported to be fine.

Event Description

Biomed reported the system has poor image quality in dark mode.The screen is reported to go blank, however, in dim mode, the screen is reported to be fine.

Manufacturer Narrative

H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 quality in dark mode.When the scanner is in the high contrast mode the acoustic image is normal is confirmed, the root cause of the reported problem is corrupted software.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) showed no other similar product 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: 8001455
• MDR Text Key: 124984069
• Report Number: 3006260740-2018-03007
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1