Model Number 8120 |
Device Problems
Break (1069); Contamination (1120); Corroded (1131); Crack (1135); Component Missing (2306); Failure to Calibrate (2440); Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2023 |
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 the 8120 pca had displayed an alarm - error codes / messages and also damaged.There was no patient involvement.
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Event Description
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It was reported that the 8120 pca had displayed an alarm - error codes/messages and also damaged.There was no patient involvement.
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Search Alerts/Recalls
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