Model Number 861290 |
Device Problems
Device Alarm System (1012); Device Displays Incorrect Message (2591)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/19/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
|
|
Event Description
|
It was reported to philips that the device ready for use indicator (rfu) showed "x".There was no patient involvement.
|
|
Manufacturer Narrative
|
The manufacturer's authorized field service engineer (fse) evaluated the device and confirmed the reported problem.Upon conclusion of the evaluation, it was determined that this was a malfunction of the therapy capacitor and battery for which parts were ordered for replacement.The device remains at the customer site and no further evaluation is warranted at this time.
|
|
Search Alerts/Recalls
|