Model Number 8120 |
Device Problems
Break (1069); Crack (1135); Display Difficult to Read (1181); Inaccurate Delivery (2339); Failure to Calibrate (2440); Failure to Align (2522); Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that an 8120 pca was affected by plastic recall and syringe sizer recall.There was no reported patient involvement.
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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 this mdr report.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.
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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.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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Event Description
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It was reported that an 8120 pca was affected by plastic recall and syringe sizer recall.There was no reported patient involvement.
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Search Alerts/Recalls
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