|
Model Number CAX501T12C |
Device Problems
Contamination (1120); Corroded (1131)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/22/2023 |
Event Type
malfunction
|
Event Description
|
The manufacturer received information regarding a dreamstation expert device.The device was returned to a third-party service center.During visual inspection of the device, corrosion was found on dc insert of the device.In addition, there was connector oxide contamination, and the device was scrapped.This report is being submitted for the corrosion was found on dc insert of the device during service.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.
|
|
Manufacturer Narrative
|
H3 other text : device serviced by a third-party service center.
|
|
Manufacturer Narrative
|
The manufacturer received information in relation to a dreamstation expert unit.The device was returned to a third party service center.During visual inspection of the device, it was determined the corrosion on dc insert.Device was scrapped at customer's request.Analysis of past events has not indicated an adverse event has occurred due to corrosion.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.Additionally, the risk file indicates that corrosion will not substantially affect the performance of the device.This complaint is considered not reportable.
|
|
Search Alerts/Recalls
|
|
|