Model Number ROTAFLOW DRIVE |
Device Problems
Device Displays Incorrect Message (2591); No Flow (2991); Noise, Audible (3273)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/31/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device will be evaluated by a maquet field service technician.A follow-up medwatch will be submitted if additional information becomes available.
|
|
Event Description
|
It was reported that the rotaflow got the signal error.The unit was reset and the flow stopped and the device started making a noise.Additional information: the incident occurred during patient treatment, no negative consequences for the patient or a delay in therapy were reported.(b)(4).
|
|
Manufacturer Narrative
|
A maquet field service technician was on site and investigated the unit.The technician determined that the root cause is the drive unit.The console operated as it should.A supplemental medwatch will be submitted if additional informations becomes available.
|
|
Event Description
|
(b)(4).
|
|
Search Alerts/Recalls
|