Model Number 8120 |
Device Problems
Break (1069); Corroded (1131); Pumping Stopped (1503)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
Event Type
malfunction
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Event Description
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It was reported the pca module "alarmed and shut off" customer reports no error message was received prior to shutting down.There was patient involvement however no patient harm.
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Manufacturer Narrative
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Per 803.52(f)(11)(iii).The information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.H3 other text : see manufacturer narrative.
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Manufacturer Narrative
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A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.
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Event Description
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It was reported the pca module "alarmed and shut off" customer reports no error message was received prior to shutting down.There was patient involvement however no patient harm.
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Search Alerts/Recalls
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