Model Number 1488010001 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Unintended Electrical Shock (4018)
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Patient Problems
Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2021 |
Event Type
Injury
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Event Description
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It was reported that the user was shocked.
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the user was shocked.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: shocked when unplugged.Probable root cause: isolation circuit failure.Power supply.Filter / fuse.Ac inlet board.Manufacturing/ service nonconformity use error the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Search Alerts/Recalls
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