Catalog Number 0250080233 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that the insulation had been compromised.
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Manufacturer Narrative
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The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Alleged failure: failed insulation.The probable root cause could be third party repair.Although the product passed the insulscan, the failure identified in the investigation is consistent with the complaint record because insulation has been replaced by a third party.Manufacture date is not known.(b)(4).
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Event Description
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It was reported that the insulation had been compromised.
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Search Alerts/Recalls
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