Model Number 0475100000 |
Device Problems
Thermal Decomposition of Device (1071); Activation Failure (3270)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2022 |
Event Type
malfunction
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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 there was a thermal event.
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Manufacturer Narrative
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Alleged failure: just got this unit back from repair, tried to use it and it smelled like something was burning upon first use.Salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The root cause is the rf board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was a thermal event.
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Search Alerts/Recalls
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