Catalog Number 66802134 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Information (3190)
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Event Date 10/26/2020 |
Event Type
malfunction
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Event Description
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It was reported that during treatment, the renasys touch device had a charging problem, which caused the patient to stop the therapy.It is unknown how the treatment was completed.An injury to the patient was reported, but further details are not known.
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Event Description
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It was reported that during treatment, the renasys touch device had a charging problem, which caused the patient to stop the therapy until a back-up device was delivered.Treatment was completed with the back-up device.
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Manufacturer Narrative
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H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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