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Catalog Number EMAX2PLUS |
Device Problems
Device Alarm System (1012); Fail-Safe Problem (2936)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: e1: reporters phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi (b)(4).
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Event Description
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It was reported from taiwan that the console of the motor device was displaying an e6 error (overheat warning) message.It was not reported if the event occurred during a surgical procedure.It was not reported if there was a delay to a planned procedure.It was not reported if there was a spare device available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2023.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the motor device was displaying an e6 error code (overheat warning), would not run, the locking components were damaged, the device would run in the locked position, and foreign substance/debris/cleaning/sterilization.It was further determined that the device failed pretest for motor thermistor assessment and safety assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to the user, which is user error.
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Search Alerts/Recalls
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