Model Number 8120 |
Device Problems
Calibration Problem (2890); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
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 a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event.[[service type]];[alaris pca device alarms indicating calibration is required.].There was no reported patient involvement.
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Manufacturer Narrative
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Correction: describe event or problem.Annex b: b21.Annex c: c21.Annex d: d16.Additional information: annex a: a25.Annex b: b01.Annex c: c19.Annex d: d15.
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Event Description
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It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event.[depot repair];[alaris pca device alarms indicating calibration is required.].There was no reported patient involvement.
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Search Alerts/Recalls
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