Catalog Number 3010901 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/16/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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The customer reported that paddle spoon of their internal defibrillation paddles assembly would not lock into place and would fall out.In this condition, the internal paddles could not be used to deliver defibrillation therapy to a patient, if needed.There was no patient use associated with the reported issue.
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Manufacturer Narrative
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The customer was provided with a replacement internal defibrillation paddle handles assembly and internal paddles (spoons).Physio-control evaluated the customer's internal defibrillation paddle handles assembly but was unable to duplicate the reported issue.The assembly passed both a visual inspection and insertion test.The internal defibrillation paddle handles assembly was tested with all six (6) sets of spoons that the customer returned along with the assembly and it was observe that the shaft of the spoons would move freely inside the handle insert and would lock appropriately in the handle.Additionally, it was observed that the assembly passed all charge and shock tests.The cause of the reported issue could not be determined.
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Manufacturer Narrative
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Lot number of the follow-up medwatch report should have included - 1501.The follow-up medwatch report should have included a return date of 09/09/2015.
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Search Alerts/Recalls
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