Model Number 866199 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2024 |
Event Type
malfunction
|
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
|
Philips received a complaint on the defibrillator indicating that the device needs an inspection.Information regarding specified malfunction has been requested.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
|
Multiple attempts were made to obtain the device evaluation, repair, and operational status with no approval from the customer.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Multiple attempts were made to obtain the device evaluation, repair, and operational status with no approval from the customer.No further information was provided.
|
|
Manufacturer Narrative
|
Updating reporting decision to not reportable based on review of the completed investigation.This case is about contract review, no any reportable malfunction was alleged.Non-reportable as there was no death or serious injury reported, and the observed event/issue would not impact therapy if it were to recur.Thus this emdr follow up is submitted to address the reportability change.
|
|
Manufacturer Narrative
|
As per further investigation, philips distributor confirmed the customer is interested in hiring philips to take care of all these equipments.The equipments was only submitted for prior inspection for maintenance contract, so there was no equipments maintenance yet.No any malfunction was alleged.This emdr follow up was initiated to address that this case was updated to a non-complaint.
|
|
Search Alerts/Recalls
|