It was reported to philips that one of the pads is not able to be teared apart.From the picture, it seems the gel was attached to the wrong position.There was reportedly 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.
|
The pads (lot 011223-06) were returned to philips for additional analysis.The complaint was escalated for technical complaint investigation and the results indicate that one of the pads had been placed on the non-laminated side of the pads liner and could not be removed.As a result, the pads could not be fully tested.Based on the information available and the testing conducted, the cause of the reported problem was that one of the pads had been placed on the non-laminated side of the pads liner and could not be removed.The reported problem was confirmed.The customer was provided with replacement pads to resolve the issue.It has been concluded that no further action is required at this time.
|