Catalog Number 0250040112 |
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 02/26/2018 |
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 was compromised.
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known.Alleged failure: instruments failed customers test.Chunks of coating came off the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be third party repair.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.
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Event Description
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It was reported that the insulation was compromised.
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Search Alerts/Recalls
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