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Model Number 2110 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
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Event Description
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It was reported that the device exhibited an unspecified system error code.There was no physical damage or abuse, no delay of therapy, no patient involvement and no patient harm.
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Search Alerts/Recalls
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