Catalog Number 0250080617 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.Mfg date: the date of manufacture 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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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: insulation failure the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.The device manufacturer 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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