MAUDE Adverse Event Report: VYAIRE MEDICAL 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems Loose or Intermittent Connection (1371); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2023

Event Type  Injury  

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.However, the unit was thoroughly check by the 3rd party.Analyze and observe the unit in workshop for an hour.Units all data were under specifications and working good.It seems to be from the patient circuit side, unit is in good working condition.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text: device not returned yet.

Event Description

It was reported to vyaire medical that the 3100a ventilator suddenly shut off while on a patient.Initiated ambu bagging and replaced machine with new one.The patient were reconnected to the new ventilator and the patient remains stable.As of this time there is no information about patient harm associated with this reported event.

Manufacturer Narrative

Correction: h6: corrected device code and health effect - impact code f26.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18398405
• MDR Text Key: 331389530
• Report Number: 2021710-2023-18570
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003062
• UDI-Public: (01)10846446003062
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768909
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention