Model Number 866199 |
Device Problem
Disconnection (1171)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2021 |
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 connection cable for the external paddles was missing.Patient involvement information is currently unknown, but 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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Event Description
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It was reported to philips that the connection cable for the external paddles was missing.Device was in clinical use but no reported 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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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.
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Search Alerts/Recalls
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