VYAIRE MEDICAL INC. 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY
|
Back to Search Results |
|
Model Number 3100 A |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/19/2019 |
Event Type
Death
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported to vyaire medical that the 3100a ventilator malfunctioned and/or shut off without warning leading to acute decompensation and hypercapnia.Currently, there is no information as to the intervention that took place in the hospital immediately following the reported event.The patient's blood was tested and their blood culture came back positive.The patient was placed on antibiotics to treat the positive blood culture.The doctors recommended to the patient's parents that they removed support.The patient passed away once support was removed.
|
|
Search Alerts/Recalls
|
|
|