MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. CLICK FLOWMETER, O2, 0-25LPM, OHMEDA; FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED

Model Number 12510-OH-D

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/25/2023

Event Type  Other  

Event Description

Nonfictional flowmeter out of manufacture package.

• Brand Name: CLICK FLOWMETER, O2, 0-25LPM, OHMEDA
• Type of Device: FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.
• MDR Report Key: 17020223
• MDR Text Key: 316229409
• Report Number: MW5117966
• Device Sequence Number: 1
• Product Code: CAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2022
• Device Model Number: 12510-OH-D
• Device Lot Number: 678144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1