Model Number N/A |
Device Problem
Loss of Power (1475)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
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Event Description
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It was reported that the air dermatome was in need of repair for unit stopped during surgery.Event occurred during surgery.No harm and no delay.No additional information available.No adverse event was reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Product review of the electric dermatome serial number (b)(6) by zimmer - japan on 22 april 2020 revealed that the unit did not work.Repair of the device was not performed because the account did not want to continue with the repair.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
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Event Description
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No additional event details.
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Search Alerts/Recalls
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