Model Number 866199 |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation.
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Event Description
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It was reported to philips that the screen did weird things.// patient involvement information is currently unknown, but no adverse event.The efficia (b)(4) defibrillator, model# 866199, is substantially similar to the heart start xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
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Event Description
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It was reported to philips that the screen did weird things.Related patient involvement information is currently unknown, and request has been sent out for such information.However, there is no adverse event.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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Complaint evaluation the customer evaluated the device and received remote support from the customer care solution center, during which onsite diagnostic service was offered to the customer.Customer resolution and conclusion multiple attempts were made to obtain the device evaluation, repair, and operational status with no response from the customer.No further information was provided.A supplemental report will be submitted if new information is obtained.H3 other text : multiple attempts were made to obtain the device evaluation, repair, and operational status with no response from the customer.No further information was provided.A supplemental report will be submitted if new information is obtained.
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Search Alerts/Recalls
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