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

Catalog Number 9770176

Device Problems Loss of Power (1475); Charging Problem (2892)

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 device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.Device has not been returned, at this time.

Event Description

Per tm: vision ii system is not able to hold a charge and system is shutting itself down without warning in the middle of procedures.

Event Description

Per tm: vision ii system is not able to hold a charge and system is shutting itself down without warning in the middle of procedures.

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 shutting down during use was unconfirmed.The tower as a complete system powered on and ran for a few hours without a shutdown.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No other functionality issues with the equipment were found during evaluation/servicing.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

• Brand Name: SITE~RITE VISION II DISPLAY
• 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: 7340122
• MDR Text Key: 102591245
• Report Number: 3006260740-2018-00440
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K132942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770176
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1