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Catalog Number 5C4471 |
Device Problem
Unintended Electrical Shock (4018)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2023 |
Event Type
malfunction
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Event Description
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It was reported a patient felt electrical shock with a homechoice automated pd system.At the start of therapy while touching the buttons, the patient felt a "jolt" that lead to a burning sensation in their hands.The patient was sitting/standing with their shoes on at the time of the event.The patient cleaned the unit with alcohol.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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D4: lot # (remove 29275 and add na).D4: remove na and replace with 29275.H10: the device was received for evaluation.An event history log review was not performed because the device log was illegible.A visual inspection of the device was performed, and no physical damages were found related to the reported condition.Functional testing was not possible because the equipment was not operating.The reported condition could not be verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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