Model Number N/A |
Device Problems
Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2022 |
Event Type
Injury
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Event Description
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It was reported that a defect was discovered when the machine was checked at the beginning of the operation.Despite the replacement of the battery and the battery housing, the machine did not work and since no more machines were available that day, the operation had to be cancelled.The patient was already under anesthesia and had to be discharged.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: universal aseptic transfer kit housing (item # 89-8510-440-10, lot # 5016462).Report source ¿ foreign ¿ germany.Multiple mdr reports were filed for this event, please see associated reports: 0008031000 - 2022 - 00058.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Event Description
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No further event information available at the time of this report.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h8, h10.Diagnosis data and analysis: unstuck lid - charge issue the product is not technically repairable; it is not under warranty anymore so it was not replaced.Device has been recycled in zimmer geneva premises as per customer instruction.The device is used for treatment.Dhr review was performed.Device was 10 months old and is not out of box failure.With the available information, a definitive root cause cannot be determined.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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