C.R. BARD, INC. (BASD) -3006260740 SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
|
Back to Search Results |
|
Catalog Number 9770600Y |
Device Problems
Poor Quality Image (1408); No Apparent Adverse Event (3189)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/05/2024 |
Event Type
malfunction
|
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
|
|
Event Description
|
User is reporting poor imaging.No other information was provided.
|
|
Event Description
|
User is reporting poor imaging.No other information was provided.
|
|
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 device was returned to the service facility for evaluation.During evaluation, the reported issue of poor imaging was unconfirmed.The sr8 was tested and produces a good image quality.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.H3 other text : evaluation findings are in section h11.
|
|
Search Alerts/Recalls
|
|
|