Model Number 4000-0105-51 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported the device motor was not running.No patient injury was reported.
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Manufacturer Narrative
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Other text: b3: unknown; no information has been provided to date.Device evaluation: one device was returned for analysis in used condition.Visual inspection showed the plunger tamper seal was broken, the top case was chipped and the bottom case was cracked.Review of the event history log showed an occurrence of a "motor not running" error message.Functional testing found that the device exhibited "motor not running" as the start of the occlusion test.It was observed that the worm coupling was not turning at all.The investigation determined that normal wear was the cause of the reported issue.It was noted that the stepper motor was six years old and the pin was loose and not turning properly.The stepper motor was replaced to correct the issue.Preventive maintenance was also performed and the device then passed all functional tests.Service history review identified the complaint was not related to a previous service of the device within the review period.
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Search Alerts/Recalls
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