Model Number 1488010000 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)
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Patient Problems
Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was electric shock to the user.
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Manufacturer Narrative
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Alleged failure: unit shocked the nurse, this is the second incident.Update - shocked when unplugging the camera head from ccu after the case.No medical attention was needed.The shock was a strong shock that was stronger than a typical static shock from walking on carpet.The device will be returned once the loaner has been delivered.Complaint was submitted for the 1st incident (b)(6) 2021.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: it is difficult to determine the root cause of the issue observed at the account since we are unable to replicate the problem in-house.Possible root causes could be an electrosurgical generator or cautery pencil near the ccu.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was electric shock to the user.
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Search Alerts/Recalls
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