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Model Number N/A |
Device Problems
Power Problem (3010); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the device was out of calibration, rpms low, and overhaul needed so the device was recalibrated and overhaul performed and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Event Description
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It was reported that there was a cut on the lead.Power cable which runs from the electric dermatome handpiece to the power supply console.Power supply is not returned with device.No frayed or exposed wiring.Investigation found the motor speed was low.No adverse event was reported as a result of this malfunction.
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Search Alerts/Recalls
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