Device Problems
No Display/Image (1183); Device Displays Incorrect Message (2591)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/04/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
|
|
Event Description
|
It was reported to boston scientific corporation that a lithovue touch pc was intended to be used in a procedure performed on (b)(6) 2022.During preparation, the lithovue touch pc was showing a user message "hardware malfunction" on the screen.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
|
|
Manufacturer Narrative
|
Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Investigation results: a visual inspection of the touch pc few scratches on the pc frame.A red circle with a red bar shows on the screen.Functional test discontinued.Touch panel pc shuts down successfully.It can be concluded that the reported showing a screen crossed out in red was confirmed during investigation.This investigation is assigned a most probable conclusion code of cause traced to component failure.This conclusion was selected because the reason showing a screen crossed out in red was duplicated/replicated during functional testing.The conclusion is acceptable because the analysis of the available information in the complaint did match/reveal the fault condition within the product.The evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, it can be concluded that component related was the most probable cause of the complaint/event.
|
|
Event Description
|
It was reported to boston scientific corporation that a lithovue touch pc was intended to be used in a procedure performed on (b)(6) 2022.During preparation, the lithovue touch pc was showing a user message "hardware malfuntion" on the screen.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
|
|
Search Alerts/Recalls
|