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Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the device was sent in for preventative maintenance.There was no patient involvement.During product evaluation, the rmps were erratic and the calibration was out at all readings.Due diligence is complete and there is no additional information available.There was no adverse event associated with the malfunction.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent record determined the rpms were erratic and the calibration was out at all readings.The customer declined the repair and the device was returned unrepaired.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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