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

Model Number 850S

Device Problem Product Quality Problem (1506)

Patient Problem Hypoventilation (1916)

Event Date 05/03/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 294903691
• Report Number: 8030673-2022-00250
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752155143
• UDI-Public: (01)50190752155143(10)0004161234(11)20200904
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 24 KG