Model Number 20E |
Device Problem
Display or Visual Feedback Problem (1184)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/27/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Stryker performed an initial evaluation of the customer's device and was not able to duplicate the reported issue.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
|
|
Event Description
|
The customer contacted stryker to report their device's screen is white.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
|
|
Event Description
|
The customer contacted stryker to report their device's screen is white.In this state the device may not be able to deliver defibrillation therapy if needed.There was no patient involvement reported with the event.
|
|
Manufacturer Narrative
|
The user interface pcba was replaced as a proactive measure.The replaced user interface pcba was tested and the issue could not verified or reproduced.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.
|
|
Search Alerts/Recalls
|