Model Number 3100A VENT,115V,60HZ,DOM |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).H3:81 other-the suspect device was not returned for evaluation, therefore a definitive root cause could not be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : currently the suspect device has not returned for evaluation.
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Event Description
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It was reported to vyaire medical that all of the displays on the 3100a unit are blank.Customer can only see the piston centering display.Customer states the unit will run fine but no displays.No patient involvement was reported.
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Search Alerts/Recalls
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