Catalog Number 72290146 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure, the werewolf controller had an error message, stating "system communication fault".The procedure was completed with the same device.There was a delay greater than 30 minutes.No further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Manufacturer Narrative
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Internal complaint reference: (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Per an additional response from the customer, it was specified that the surgical delay was less than 30 minutes; therefore; there is no risk related to anesthesia for the patient.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
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Event Description
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It was reported that during a procedure, the werewolf controller had an error message, stating "system communication fault".The procedure was completed with the same device.There was a delay less than 30 minutes.No further complications were reported.
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Search Alerts/Recalls
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