Model Number 0233050200 |
Device Problems
Thermal Decomposition of Device (1071); Failure to Shut Off (2939)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
Event Type
malfunction
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Event Description
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It was reported that there was a potential of a thermal event.
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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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Manufacturer Narrative
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The device manufacturer date is not known.Alleged failure: "it was reported by the sales rep (b)(4) the light source remained on when it was removed from the adapter on the scope ref (b)(4) salesforce case number (b)(4)" conclusion: reported failure mode could not be reproduced but reed switch function was noted to be slightly insensitive in response to safelight adapter attachment.It's possible that these issues could cause it to get stuck in either the "on" or "off" position, leading to the reported scenario where the light source fails to turn off after the safelight adapter was removed.Probable root cause is likely due to a damaged/defective reed switch.The product was returned for investigation and the failure(s) identified is consistent with the complaint record.Failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that there was a potential of a thermal event.
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Search Alerts/Recalls
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