Model Number 00-3003 |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
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Event Description
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It was reported there were device pacing failures.Additional information has been requested.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.
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Manufacturer Narrative
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This complaint has been deemed a duplicate of (b)(4).Device investigation will take place on (b)(4).
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Search Alerts/Recalls
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