Model Number 3100 A |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).Other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned yet.
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Event Description
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It was reported to vyaire medical that piston stopped on the 3100 a device.The customer confirmed there was no patient involvement associated with the reported event.
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Manufacturer Narrative
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Results of investigation: vyaire medical field service technician went onsite to evaluate the device.Customer was told that driver needed replacement and sounded bad.Technician powered up unit next to customer.Performed circuit calibration and verification.Unit was running with no issues.Customer heard the driver and didn't hear any problems.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Search Alerts/Recalls
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