MAUDE Adverse Event Report: VINCENT MEDICAL MANUFACTURING CO., LTD VENTILATOR; VEBULIZER (DIRECT PATIENT INTERFACE)

Model Number VHC10 INFANT HUMIDIFICATION CHAMBER

Device Problems Pressure Problem (3012); Unexpected Shutdown (4019)

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

Event Type  malfunction  

Event Description

"after starting the oscillation, the ventilator alarmed "high mean airway pressure" and stopped oscillating." this report reflects information received by fda in the form of a notification per 803.22 (b)(2).Refer to add'l documents in i2k.

• Brand Name: VENTILATOR
• Type of Device: VEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VINCENT MEDICAL MANUFACTURING CO., LTD
• MDR Report Key: 17278943
• MDR Text Key: 318612807
• Report Number: MW5119168
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: VHC10 INFANT HUMIDIFICATION CHAMBER
• Patient Sequence Number: 1