Catalog Number 826820 |
Device Problem
No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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A facility reported a cerelink monitor (id 826820) stayed with the screen in stand by without displaying the icp when it was connected to the patient.Medical staff turned off and on again but the issue persist.As the hospital have no more cerelink monitors, they had to remove the cerelink sensor from the patient and decided to monitor with an external ventricular drain.
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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N/a.
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Manufacturer Narrative
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The cerelink monitor was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.Failure analysis - monitor is not working properly, the monitor is only in boot mode.The complaint could be verified through failure analysis.Root cause - the complaint was confirmed in the complaint investigation.Per the service report, likely root cause is, a defective digital board.The digital board was replaced and monitor worked accordingly.
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Search Alerts/Recalls
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