Model Number 866199 |
Device Problem
Circuit Failure (1089)
|
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 cable was defective.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
|
Philips bench evaluated the device and determined this was a malfunction of the processor cable.Philips bench provided the customer with part number and pricing for a replacement processor cable; however, the customer did not accept the quote.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the processor cable.The reported problem was confirmed.
|
|
Search Alerts/Recalls
|