MAUDE Adverse Event Report: VYAIRE MEDICAL 3100A; VENTILATOR, HIGH FREQUENCY

Model Number 773997

Device Problem Disconnection (1171)

Patient Problems Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

The customer reported the suspect patient circuit component is not available for analysis.However, pictures of the suspect patient circuit were received and will be forward to our quality engineering for an investigation.In the event that the suspect component is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported that the patient circuit became disconnected (the tube to the humidifier chamber slipped off or came apart from the patient circuit) while in use on a patient.No known patient harm or injury was reported with this event.

Manufacturer Narrative

Additional information: initial submission did not include the additional information relating to the patient impact.This was received on 18dec2018 from the customer.

Event Description

Additional customer information received on 18dec2018: the customer reported that the patient was manually ventilated and experienced a low oxygen saturation during this event.

Manufacturer Narrative

Results of investigation: the vyaire medical reviewed the submitted a photo associated with a patient circuit part number 773996.An observation of the photo displayed a defective area within the patient circuit.However, the tubes are properly assembled and no issues could be observed.However, the defect reported by the customer could not be confirmed, due to a lack of the alleged faulty patient circuit.Additionally, a dhr review could not be performed due to no lot number was provided for investigation.Therefore, a component root cause could not be determined.

• Brand Name: 3100A
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8173434
• MDR Text Key: 130629555
• Report Number: 8030673-2018-00019
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 20846446003373
• UDI-Public: (01)20846446003373
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 773997
• Device Catalogue Number: 773996
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention