Model Number 866199 |
Device Problems
Degraded (1153); Electrical /Electronic Property Problem (1198)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/06/2024 |
Event Type
malfunction
|
Event Description
|
It was reported to philips that the efficia dfm100 exhibited worn out external paddles.There was no reported patient impact or injury.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
|
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporting address line: (b)(6).
|
|
Manufacturer Narrative
|
This report is based on information provided by philips remote service engineer (rse) and with an investigation documented by philips complaint handling.Philips received a complaint on the efficia dfm100 defibrillator indicating that the device's external paddles cable is worn out.The device was evaluated by hospital biomed with the support of the philips rse.Based on the results of the analysis, it was determined that the product has malfunctioned and the cause of the reported problem was a defective external paddles cable.The issue was resolved with the replacement of the defective paddle repl.Kit water resistant and the device was returned to service.Based on the information available and results of additional analysis, no further action is necessary at this time.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.If additional information is received, the complaint file will be reopened for further investigation.H3 other text : remote support provided.
|
|
Search Alerts/Recalls
|