Model Number N/A |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.Telephone number: (b)(6).
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Event Description
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It was reported that outside of surgery during repair the device was out of calibration.Due diligence is complete and there is no additional information available.No adverse event is associated with this malfunction.
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Event Description
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This device did not cause or contribute to serious injury.Therefore this is not reportable; the initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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This device did not cause or contribute to serious injury.Therefore, this is not reportable; the initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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