REMOTE DIAGNOSTIC TECHNOLOGIES LTD. TEMPUS PRO; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
|
Back to Search Results |
|
Model Number 00-1024-R |
Device Problems
Computer Software Problem (1112); Appropriate Term/Code Not Available (3191)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/30/2022 |
Event Type
malfunction
|
Event Description
|
The customer reported received system back from bench with updated software plugged cmac usb imager machine shut down.Unit "shutdown when i plugged in video laryngoscope and hit image capture." vl was not unplugged.A user report was received related to a reported product problem which is currently being investigated.At the time of reporting, the device has not yet been returned for investigation.Further updates will be provided when the device is received, and the investigation is in progress.
|
|
Manufacturer Narrative
|
This report is based on information provided by philips repair service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that after the device received back from bench, unit shutdown when video laryngoscope plugged in and hit image capture.Vl was not unplugged.Based on the information available and the testing conducted, the cause of the reported problem was confirmed.The units under investigation with rdt to determine a solution for this issue.This failure mode was escalated to r&d for additional investigation.The primary root cause was identified as inadequate software verification and validation.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The investigation concludes that no further action is required at this time.
|
|
Search Alerts/Recalls
|
|
|