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

Model Number UNKNOWN

Device Problem Connection Problem (2900)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/26/2023

Event Type  Injury  

Event Description

It was reported to vyaire medical that a patient was on the oscillator when it lost pressure and alarmed low pressure.The patient started to desaturate.End users performed manual ventilation, and saturation went back within range.An attempt was made to restart the oscillator but could not restart.Upon checking for leak, it was found that the boxed patient circuit assy, 3100a, 850s (attached to the humidifier) had popped off despite cable tie (x1) in place.An extra cable tie was added, and issue was resolved.The patient was placed back on the oscillator.Due to the incident, the patient derecruited and desaturate.Settings were increased from 50% to 80% fio2 (fraction of inspired oxygen), 18.4 cmh2o to 20 cmh2o map (mean airway pressure), and 76 to 83 amplitude.

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.

• Brand Name: BOXED PATIENT CIRCUIT ASSY, 3100A, 850S
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción n; o. 85, parque undustrial mexic; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18022342
• MDR Text Key: 326744493
• Report Number: 2021710-2023-18315
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 20846446064114
• UDI-Public: (01)20846446064114
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2023

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: UNKNOWN
• Device Catalogue Number: 29028-003
• Device Lot Number: 0004155820
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Sex: Female
• Patient Weight: 5 KG