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Model Number 8120 |
Device Problems
Break (1069); Corroded (1131); Crack (1135); Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Nonstandard Device (1420); Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2021 |
Event Type
malfunction
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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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Event Description
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It was reported that an 8120 pca was affected by plastic recall.During servicing, it was found display board- segment dim, iui- corrosion, isolation rib damage, flange gripper- damaged/cracked, module latch- damaged/cracked, label- damaged.There was no reported patient involvement.
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Manufacturer Narrative
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Additional information: device available for eval?, returned to manufacturer on, imdrf annex a, g, b, c and d grids, remedial action required, remedial action #.
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Event Description
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It was reported that an 8120 pca was affected by plastic recall.During servicing, it was found display board- segment dim, iui- corrosion, isolation rib damage, flange gripper- damaged/cracked, module latch- damaged/cracked, label- damaged.There was no reported patient involvement.
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Search Alerts/Recalls
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