Model Number 866199 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/26/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).A follow up report will be submitted upon completion of the investigation.
|
|
Event Description
|
Philips received a complaint on the defibrillator indicating that the device failed quality inspection.There was no patient involvement.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.
|
|
Manufacturer Narrative
|
This is non-complaint, fse confirmed the hospital equipment engineer wants to know how to do dfm100 self-test, user did not provide serial number.Fse guided the user run self-test, no device has problem.
|
|
Search Alerts/Recalls
|