Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Code Available (3191)
|
Event Date 03/21/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product code: itx.(b)(4).This event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
|
|
Event Description
|
A doppler crystal prematurely separated from the cuff and the patient had to go through an additional procedure to replace the doppler.
|
|
Manufacturer Narrative
|
Investigation summary: the complaint device was not returned and therefore a physical investigation could not be completed.The device history record was reviewed.There is no evidence that a defective product was manufactured.There are no signs that this cuff was detached prior to shipment or that this device was not manufactured to current specifications.Crystal epoxy separation is a known failure of this device.Capa 161942 was initiated to capture the correction activities of this failure.
|
|
Search Alerts/Recalls
|