Model Number 201-30105 |
Device Problem
Electrical /Electronic Property Problem (1198)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/23/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
|
|
Event Description
|
It was reported that the centrimag console alarmed battery module fail twice and the alarm hasn't repeated.The doctor was at the bedside when this happened and elected not to change the console.It was reported it was advised to keep a backup available and not transport the patient without being informed.The battery indicator shows 3.45h and the console has been plugged in the entire time.The rpms were 3800 with 4.5 l/min flow.No adverse event reported, and no additional information reported.
|
|
Manufacturer Narrative
|
No further information was provided.
|
|
Manufacturer Narrative
|
Manufacturing investigation conclusion: the reported event of damage to the flow probe was confirmed.The centrimag flow probe (serial #: (b)(6) was returned for analysis and was evaluated and tested under work order: 54176585.The flow probe was tested and functioned as intended.Damage observed to the flow probe cable, exposing the shielding underneath; however, there was no damage to any underlying wires.The flow probe was connected to a test centrimag system and always functioned as intended.The root cause for the damage was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.
|
|
Search Alerts/Recalls
|