MAUDE Adverse Event Report: VYAIRE MEDICAL INC. BOXED PATIENT CIRCUIT ASSY, 3100A, 850S; VENTILATOR, HIGH FREQUENCY

Model Number BOXED PATIENT CIRCUIT ASSY, 3100A, 850S

Device Problem Product Quality Problem (1506)

Patient Problems Hypoventilation (1916); Low Oxygen Saturation (2477)

Event Date 04/09/2022

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.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 the patient's co2 went up to 12 and then 20 even though the oscillator was able to oxygenate the patient, and this could not be cleared on lower frequency or increased amplitude.Also, there were severe "rainouts" or copious amounts of water in water trap, tubing and filters.The map was fluctuating, causing patient to desaturate.End users immediately attended to the patient and made the situation safe by clearing condensation from the system (water trap required emptying twice in 4 hours), changing to a different oscillator without a filter, or putting the patient back onto conventional ventilation.The issue have occurred multiple times ((b)(4)) on different oscillators.However, current opinion of the end users is that it could be related to the boxed patient circuit assy, 31a, filtered, 850s as no noticeable problem with old patient sets (no filter).Co2 - carbon dioxide.Map - mean airway pressure.

• Brand Name: BOXED PATIENT CIRCUIT ASSY, 3100A, 850S
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• 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: 15059691
• MDR Text Key: 296210081
• Report Number: 8030673-2022-00260
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003192
• UDI-Public: (01)10846446003192(10)0004161234
• 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: 06/22/2022

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: BOXED PATIENT CIRCUIT ASSY, 3100A, 850S
• Device Catalogue Number: 11518-850S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: No
• 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