Model Number 866199 |
Device Problems
Failure of Device to Self-Test (2937); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The rse (remote service engineer) confirmed by contacted customer.The lead wire cannot pass the self-test.The customer requested a replacement.New ¿989803145121 3 lead set, snap, iec, icu¿ was sent to customer solve the issue.
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Manufacturer Narrative
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(b)(6).A follow up report will be submitted upon completion of the investigation.
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Event Description
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Philips received a complaint on the defibrillator indicating that the newly installed lead wire cannot pass the self-inspection.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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Search Alerts/Recalls
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