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

Catalog Number 9770066

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.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

Biomed reported system displays horizontal lines on the screen, preventing visualization of ultrasound.

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 system displays horizontal lines on the screen preventing visualization of ultrasound was unconfirmed.The scanner powers on and boots up normally.No jumping or flickering of the display was observed during the evaluation.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Biomed reported system displays horizontal lines on the screen, preventing visualization of ultrasound.

• Brand Name: SITE~RITE 6 SCANNER
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7678066
• MDR Text Key: 113889124
• Report Number: 3006260740-2018-01677
• 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: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/20/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 05/19/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1