Model Number 866199 |
Device Problems
Mechanical Problem (1384); Mechanics Altered (2984)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/26/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Reporter last name: (b)(6).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
|
Philips received a complaint on the defibrillator indicating that the right side pacer handle damaged.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
|
The rse (remote service engineer) confirmed by contacted customer.The defibrillator right side pacer handle damaged.The customer requested a replacement.A new ¿453563476991 paddle repl.Kit water resistant¿ was sent to the customer to solve the issue.
|
|
Search Alerts/Recalls
|