Model Number 866199 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
Event Type
malfunction
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Event Description
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It was reported the device had ecg issues.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.
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Manufacturer Narrative
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This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on efficia dfm 100 indicating that device is experiencing ecg issues.The device was evaluated by the philips fse at the customer¿s site.The fse recommended to replace ecg cable as it was defective (quote sent to the customer, but the customer did not order the cable from philips).The device returned to full functionality.Based on the information available and the testing conducted, the cause of the reported problem was a defective ecg cable.The reported problem was confirmed.The fse recommended replacement of the ecg cable to resolve the issue and the device returned to service.
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Search Alerts/Recalls
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