MAUDE Adverse Event Report: VYAIRE MEDICAL, INC 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A VENTILATOR

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

H3: 81 other - the customer reported that they will not return the defective unit/part for evaluation.Therefore, no root cause could be determined.However, the customer emailed back and confirmed that he did not find the air connection loose.Additionally, oscillation never stopped and no water was found in any of the colored cap diaphragms.Customer will perform a circuit calibration and performance check, and if everything goes fine, the device can go back to service.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.".

Event Description

It was reported to vyaire medical problem with 3100a ventilator regarding loose air hose connection on back of the unit.It has been indicated that high pitch squealing started coming from the air hose in the back of the oscillator, loose connection, unsafe to adjust while on patient, so equipment was exchanged.Patient tolerated well.No need for manual bagging swift exchange with machines placed next to each other.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 17796082
• MDR Text Key: 324004254
• Report Number: 2021710-2023-18190
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2023

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: 3100A VENTILATOR
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/22/2023
• 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