COOK MEDICAL, LLC/ COOK VANDERGRIFT INC COOK-SWARTZ DOPPLER PROBE, STANDARD CUFF; TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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Model Number G21363 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/06/2019 |
Event Type
malfunction
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Event Description
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Doppler was placed with no issues; six days afterward it was removed.Removal done per manufacturer instructions; however, tip of wire was noted to be separated/broken.No plan to retrieve wire from patient, no harm to patient.Fda safety report id #: (b)(4).
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