Catalog Number V041079000000 |
Device Problems
Mechanical Problem (1384); Intermittent Energy Output (4025)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it is reported that a vdw gold/silver contra angle stops during treatment.Outcome of event/patient injury is unknown as of this mdr.Additional information pending.
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Manufacturer Narrative
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This report is for additional information received that there was no injury that occurred in this event.
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Manufacturer Narrative
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Battery (voltage collapses under load) defective, replaced.Contra angle 47152 (2012) (has increased resistance and is therefore unsuitable for measurements on patients) defective, replaced with wkst.129609 (2018).Gmr1447824 and foot control 162344 reviewed.As part of the review, we updated the device software.The case is cracked (probably due to an impact) but has no effect on the function.Function test and test measurements without errors.
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Search Alerts/Recalls
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