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Model Number 029-4739-02 |
Device Problems
Break (1069); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This report is a consolidation of reports summarized as part of the fda voluntary malfunction summary reporting program.1 event was reported in quarter 3 of 2020.The 1 event did not have patient or user involvement, and did not result in injury.At the time of this report, a physical investigation could not be completed due to the device being unavailable for evaluation.However, after reviewing pictures provided by the user facility it appears that a weld on the downtube causing the monitor to fall.A replacement downtube was sent to the user facility.
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Event Description
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This report summarizes 1 malfunction event.The 1 event stated the weld broke on monitor mount down tube and monitor was found hanging on by its wires.The 1 event reported no patient, or user injury, it broke between patients.
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Search Alerts/Recalls
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