Model Number 3100A |
Device Problems
False Alarm (1013); Device Sensing Problem (2917)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/15/2023 |
Event Type
malfunction
|
Event Description
|
It was reported to vyaire medical that the 3100a alarming incorrectly.As of this time there is no information about patient involvement associated with this reported event.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Result of investigation: vyaire field service went onsite discovered faulty lower thumb wheel alarm control upon inspection of the ventilator.As a resolution, per service manual it was replaced and both of the alarm controls are within in specifications.Ventilator is ready for use.Additional information:the reported issue happened during patient use.The vent was alarming low pressure/high pressure alarm accuracy.The customer confirmed that there was no patient harm associated with the reported event.
|
|
Search Alerts/Recalls
|