Model Number CPRM1116 |
Device Problems
Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
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Event Type
malfunction
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Manufacturer Narrative
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The affected device was not returned.Visual inspection and functional testing was performed on current inventory.Out of the inventory that was evaluated two devices were found to be loose and not seating correctly, this confirmed customer claim, in which the patient valve separated at the c-ring connection.A nonconformance has been opened to further investigate this defect.
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Event Description
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The customer alleges that " elbow broke apart on the resus bag." no other details were provided and no patient injury/harm reported.
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Manufacturer Narrative
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Entered the wrong product code.The product code is btm.
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Event Description
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The customer alleges that " elbow broke apart on the resus bag." no other details were provided and no patient injury/harm reported.
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Search Alerts/Recalls
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