|
Model Number 509047 |
Device Problem
No Flow (2991)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Unometersafeti=110cm 1.5l rh (1/10pk)int.(b)(6).Based on the available information, this event is deemed a product malfunction.No patient harm was reported.Additional details have been requested but, not provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).
|
|
Event Description
|
It was reported that "the urine did not flow into the collection room" of the device.The device was removed.No further information was available.
|
|
Manufacturer Narrative
|
Updated common device name.Updated device evaluated to no.Updated device manufacture date.(b)(4).Corrected usage of device from initial use of device to unknown.A batch record review was performed.A non-conformance is associated with this complaint, which is closed.The investigation concludes that the likely root cause for the issue ¿stop flow between patient and chamber of unometer product¿ cannot be identified on the base of information received.No corrective action is required.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process.No additional information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).
|
|
Search Alerts/Recalls
|
|
|