Model Number SPL-PDBX376 |
Device Problems
Break (1069); Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Device was evaluated.Inspection of the device confirmed the reported issue.Damaged probe stuck with the transducer horn was observed.Device is non repairable.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.
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Event Description
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It was reported that the device was found with broken component, debris was observed coming off from the unit, something seems stuck and would not get out.There was no patient involvement on this event.No user injury reported.
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Manufacturer Narrative
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This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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