Model Number 866199 |
Device Problem
Computer Software Problem (1112)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2023 |
Event Type
malfunction
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Event Description
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Philips received a complaint on the defibrillator indicating that the device needs a software upgrade.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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Reporting address line 1: (b)(6).Reporter city: (b)(6).Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporting institution phone: (b)(6).Reporter phone: (b)(6).A follow up report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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As per the good faith effort response, there was no device malfunction, only request from customer for addition of spo2 board which already from customer spares.
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Search Alerts/Recalls
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