Model Number 00-3020 |
Device Problems
Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cardiac Arrest (1762); Insufficient Information (4580)
|
Event Date 08/08/2022 |
Event Type
Death
|
Event Description
|
As described by the customer 'unit failed to display during patient care'.During evaluation stage, customer confirmed death of patient.Unit would not display ecg waveforms during patient monitoring.Philips rdt planning to receive the device for the investigation".
|
|
Manufacturer Narrative
|
Philips received a complaint on the tempus ls indicating that device was not displaying ecg waveforms, in pads mode during a patient care event.The technical investigation of the log file analysis concluded that the device did not show any abnormalities or even a malfunction.The reported problem was not confirmed.A review of the risk management file was performed.This complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
|
|
Manufacturer Narrative
|
Updated evaluation method code grid originally provided on mfr# 3003832357-2022-00026.
|
|
Search Alerts/Recalls
|