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

Model Number	773997
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8173434
• Report Number: 8030673-2018-00019
• Device Sequence Number: 2024928
• Product Code: LSZ
• UDI-Device Identifier: 20846446003373
• UDI-Public: (01)20846446003373
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 773997
• Device Catalogue Number: 773996
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 01/09/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 12/18/2018; 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention