Model Number 866199 |
Device Problems
Device Alarm System (1012); Failure of Device to Self-Test (2937)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/01/2023 |
Event Type
malfunction
|
Event Description
|
Philips received a complaint on the efficia dfm100 defibrillator/monitor indicating that the device had abnormal alarm.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
|
Reporting address line 1: (b)(6).Reporter city: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone: (b)(6).Reporter phone: (b)(6).A follow up report will be submitted upon completion of the investigation.
|
|
Event Description
|
This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 indicating that device was alarming.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
|
Reporting address line 1: (b)(6).Reporter city: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone: (b)(6).Reporter phone: (b)(6).
|
|
Search Alerts/Recalls
|