Catalog Number IAP-0500 |
Device Problems
Communication or Transmission Problem (2896); Computer Operating System Problem (2898); Operating System Version or Upgrade Problem (2997)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/01/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
Parts were discarded.
|
|
Event Description
|
It has been reported via a field service report: (b)(4).
Symptom: op-on patient.
Fos is not working.
Findings/action taken: perform functional check - confirmed fiber optic sensor (fos) not working.
Found and replaced defective fos print circuit board (pcb) and old fos connector.
Fos now - checks ok.
Fcn level: 1416.
Software level: 2.
24.
Per the field service engineer, on tuesday (b)(6) 2017 the pump was not recognizing when a fos balloon was inserted.
They just swapped the pump with another one and continued as normal.
No patient complications.
The field service engineer (fse) replaced a defective fos pcb to repair the problem.
The board was one of the old style boards.
The fos slider was old so he replaced that as well.
|
|
Manufacturer Narrative
|
Teleflex did not receive the device for analysis.
The reported complaint of "fos not recognized" was confirmed by the field service engineer.
The root cause of the reported complaint is undetermined.
A device history record (dhr) review was conducted for the iap serial and lot number with no relevant findings.
The device passed all manufacturing specifications prior to release.
Teleflex will continue to closely monitor.
|
|
Event Description
|
It has been reported via a field service report: l612131.
Symptom: op-on patient.
Fos is not working.
Findings/action taken: perform functional check - confirmed fiber optic sensor (fos) not working.
Found and replaced defective fos print circuit board (pcb) and old fos connector.
Fos now - checks ok.
Fcn level: 1416.
Software level: 2.
24.
Per the field service engineer, on tuesday (b)(6) 2017 the pump was not recognizing when a fos balloon was inserted.
They just swapped the pump with another one and continued as normal.
No patient complications.
The field service engineer (fse) replaced a defective fos pcb to repair the problem.
The board was one of the old style boards.
The fos slider was old so he replaced that as well.
|
|
Search Alerts/Recalls
|