BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
|
Back to Search Results |
|
Model Number 9770501 |
Device Problem
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 history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.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.
|
|
Event Description
|
Bas tm reported that the screen on a site rite 8 ultrasound system with pinpoint gt shows lines running down the image as if its raining in the image.
|
|
Event Description
|
Bas tm reported that the screen on a site rite 8 ultrasound system with pinpoint gt shows lines running down the image as if its raining in the image.
|
|
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 the screen on a site rite 8 ultrasound system with pinpoint gt shows lines running down the image as if its raining in the image was confirmed.There is interference in the bottom of the image box.The root cause of the reported issue was due to an internal failure on the probe.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested and returned to customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
|
|
Search Alerts/Recalls
|
|
|