MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SR PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770086R

Device Problem Signal Artifact/Noise (1036)

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

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

It was reported by the biomedical engineer that the active ultrasound image is displayed on 2/3 of the display but the whole screen displays artifact in the form of lines running through it.

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.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 only 2/3 of the screen works and it has lines through it was confirmed.The reported issue of only 2/3 of the prevue lcd screen works and it has lines through it is confirmed.The root cause is determined to be due to a puncture in the front enclosure.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to refurbished inventory.

Event Description

It was reported by the biomedical engineer that the active ultrasound image is displayed on 2/3 of the display but the whole screen displays artifact in the form of lines running through it.

• Brand Name: REFURB, SR PREVUE PLUS
• 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: 7492884
• MDR Text Key: 107695500
• Report Number: 3006260740-2018-00909
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741124945
• UDI-Public: (01)00801741124945
• Combination Product (y/n): N
• PMA/PMN Number: K150529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770086R
• Device Catalogue Number: 9770086R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Event Location: Hospital
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1