Lot Number B0BFF3 |
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 Type
malfunction
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Manufacturer Narrative
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A recent software update to the trackwise e-mdr has resulted in the addresses for the manufacturer's contact person to be sourced from a new data location.The address issue has been corrected.(b)(4).
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Manufacturer Narrative
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Additional information will be provided once the device is returned and evaluation is completed.The record notes there was no injury associated with this event.
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Event Description
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Customer reported articulation issue with s7-3t transducer, no patient injury reported.Articulation failure when using a tee transducer during clinical use is a reportable event.
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Manufacturer Narrative
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Evaluation of the device could not confirm an articulation failure as described in the complaint.However, damage was noted on the connector, cap and window rendering this device unusable.¿.
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Search Alerts/Recalls
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