Model Number 866199 |
Device Problem
Failure of Device to Self-Test (2937)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/02/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Follow up report will be submitted upon completion of the investigation.
|
|
Event Description
|
It was reported to philips that the discharge application test failed.Patient involvement information is currently unknown, but no adverse event.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
|
|
Event Description
|
It was reported to philips that the discharge application test failed.Device was in clinical use at time of event.However, no patient harm reported.There was no adverse event.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
|
|
Search Alerts/Recalls
|