Model Number 8120 |
Device Problems
Calibration Problem (2890); Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2023 |
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 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 a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event.[[service type]];[plunger position calibration failed dose request failed].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: a020601.Annex b: b01.Annex c: c16.Annex d: d0301.Annex g: g0204002.
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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];[plunger position calibration failed dose request failed].There was no reported patient involvement.
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Search Alerts/Recalls
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