SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Model Number 72200616 |
Device Problem
Activation Problem (4042)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/01/2020 |
Event Type
malfunction
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Event Description
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It was reported that during the set up inspection, the mdu will not register into the machine.No delays or patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with recognition failure.Cause of failure is a defective electronic component.The complaint was confirmed and the root cause has been determined to be defective electronic component.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.
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Search Alerts/Recalls
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