MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE VISION II TOWER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9770177

Device Problem Display or Visual Feedback Problem (1184)

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

Nurse supervisor reported system freezes and has required a hard reboot two or three times even after reseating the wires.

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 freezing was unconfirmed.The functionality of the tower was checked and the tower showed no visual signs of the system freezing during the evaluation.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The scanner was discarded due to product discontinuance.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Nurse supervisor reported system freezes and has required a hard reboot two or three times even after reseating the wires.

• Brand Name: SITE~RITE VISION II TOWER
• 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: 7661276
• MDR Text Key: 113545874
• Report Number: 3006260740-2018-01628
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00801741095474
• UDI-Public: (01)00801741095474
• Combination Product (y/n): N
• PMA/PMN Number: K132942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770177
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Event Location: Hospital
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1