MAUDE Adverse Event Report: OXYGEN TANKS; GENERATOR, OXYGEN

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  malfunction  

Event Description

I've been getting empty oxygen tanks from this company.I've called over and over and still continue to get empty tanks.I call to complain and they take a message for the manager, and he never calls back.(b)(6).

• Brand Name: OXYGEN TANKS
• Type of Device: GENERATOR, OXYGEN
• MDR Report Key: 7596268
• MDR Text Key: 111150508
• Report Number: MW5077818
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1