MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC.; Ventilator, emergency, powered (resuscitator)

Model Number EPV200

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Event Description

Pressure sensor valve popped apart under pressure making a loud noise causing a leakage and low source gas alarm.

• Type of Device: Ventilator, emergency, powered (resuscitator)
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.
• MDR Report Key: 18024143
• MDR Text Key: 326835388
• Report Number: 1924066-2021-00001
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EPV200
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1