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 11/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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It was reported the insulation is 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 reported failure mode will be monitored for future reoccurrence.Alleged failure: broken nsulation.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.Mfg date: manufacture date is not known.(b)(4).
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Event Description
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It was reported the insulation is compromised.
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Search Alerts/Recalls
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