Catalog Number 8065750180 |
Device Problems
Device Emits Odor (1425); Loss of Power (1475); Noise, Audible (3273)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 07/26/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
|
|
Event Description
|
A materials manager reported that while getting ready for a procedure a loud "pop" was heard and smelled a burnt odor.The system shut down and would not turn back on.A different power outlet was tried, this did not resolve the issue.The case was initiated and completed using an alternate system.There was no patient involvement.Additional information was requested and received.
|
|
Manufacturer Narrative
|
The system was examined and the reported event was replicated.The power supply and the fuse were replaced to address this issue.The system was tested and found to meet product specifications.A review of the customer¿s complaint history for the last 24 months did not show any previous complaints of this kind against the system.The system was manufactured on march 17, 2004.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the non-conforming power supply.(b)(4).
|
|
Search Alerts/Recalls
|