Model Number 990066 |
Device Problems
Nonstandard Device (1420); Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/23/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.This device was included in that field action.Based on the information received and without the return of the product, it could not determine this device performed as described in the field action.(b)(4).
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Event Description
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It was reported that prior to use, multiple mapping catheter electrical cables were received missing the outer box seal.It was noted that sterile packaging was open and there was tape on the cables with numbers written on them.The cables were replaced and there was no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the achieve electrical cable was returned and analyzed.Visual inspection of the electrical cable showed that the device was intact with no apparent issues.Also, no performance testing was conducted.The cable was intended for qualification testing and was not for clinical use.A product hold order (pho) and field action were issued.In conclusion, the reported issue of a compromised and opened packaging was confirmed through testing.The cable failed inspection due to an open box and pouch.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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