MAUDE Adverse Event Report: VYAIRE MEDICAL BOXED PATIENT CIRCUIT ASSY,31A,FILTERED,850S; VENTILATOR, HIGH FREQUENCY

Model Number	850S
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Hypoventilation (1916)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.On follow-up, it was confirmed that the incident was due to the circuits as the customer sent the oscillator to medical physics and they confirmed there is nothing wrong with the equipment.The patient was back on conventional and doing is better.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that a patient with aml (acute myeloid leukemia) neutropenic sepsis and pulmonary edema and needing 100% oxygen but managing to clear co2 (carbon dioxide) was put on the 3100a.However, when on the oscillator, ph decreased from 7.4 to 6.8, and c02 increased from 6 to 21.End user performed hand ventilation and returned the patient back on the 3100a with max map (mean airway pressure) and amplitude with no improvement.Filter helped slightly.The patient was then transferred to hfov b which managed well for 24 hours until the blue filter became really wet and could not maintain map.As desaturation began, the patient was transferred to another oscillator.

• Brand Name: BOXED PATIENT CIRCUIT ASSY,31A,FILTERED,850S
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14691335
• Report Number: 8030673-2022-00250
• Device Sequence Number: 6777907
• Product Code: LSZ
• UDI-Device Identifier: 50190752155143
• UDI-Public: (01)50190752155143(10)0004161234(11)20200904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

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: 850S
• Device Catalogue Number: 11518-850S
• Device Lot Number: 0004161234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 24 KG