Catalog Number 0250040111 |
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 04/18/2017 |
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 manufacture date is not known at this time.However, should it become available it will be provided in future reports.(b)(4).
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Event Description
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It was reported the insulation failed.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: probes failed insulation test the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.The reported failure mode will be monitored for future reoccurrence.The device manufacture date is not known.Gtin: (b)(4).
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Event Description
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It was reported the insulation failed.
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Search Alerts/Recalls
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