C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
|
Back to Search Results |
|
Model Number N/A |
Device Problems
Poor Quality Image (1408); Defective Component (2292)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/15/2023 |
Event Type
malfunction
|
Event Description
|
It was reported the sr8 images are showing double images.Verified they have reseated the probe as well as power cycled it.Verified they have also adjusted filters.
|
|
Manufacturer Narrative
|
H11: section a through f - the information provided by bd 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 bd.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.
|
|
Manufacturer Narrative
|
H11: section a through f - the information provided by bd 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 bd.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 sr8 unit and probe was received in good physical condition.The reported issue of poor image is confirmed, the sr8 images are showing double images.The unit was powered up with a test probe connected and the unit operated as expected.The customer probe was connected to the unit and it was observed that the screen was very dark.
|
|
Event Description
|
It was reported the sr8 images are showing double images.Verified they have reseated the probe as well as power cycled it.Verified they have also adjusted filters.
|
|
Search Alerts/Recalls
|
|
|