Model Number 8120 |
Device Problems
Corroded (1131); Failure to Align (2522); Calibration Problem (2890); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2022 |
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]];[that is failing the preventative maintenance and calibration.It is failing the plunger force accuracy test and you can hear a really loud sound when it moves up or down].There was no reported patient involvement.
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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]];[that is failing the preventative maintenance and calibration.It is failing the plunger force accuracy test and you can hear a really loud sound when it moves up or down].There was no reported patient involvement.
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Manufacturer Narrative
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Correction: annex b: b21.Annex c: c21.Annex d: d16.Additional information: annex a: a0509.Annex b: b01.Annex c: c07.Annex d: d15.Annex g: g04061.
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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]];[that is failing the preventative maintenance and calibration.It is failing the plunger force accuracy test and you can hear a really loud sound when it moves up or down].There was no reported patient involvement.
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Manufacturer Narrative
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Correction.Annex b : b21.Annex c : c21.Annex d : d16.Additional information :remedial action required, remedial action #.Annex a : a050701,a040502.Annex c : c0601.Annex d : d01.Annex g : g0405203,g02017.
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Search Alerts/Recalls
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