MAUDE Adverse Event Report: UNKNOWN PRESSURE TUBING AND ACCESSORIES TO DELIVER PRESSURIZED MEDICAL GASES; 868.5860

Model Number 6375

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

The provider states on order (b)(4), 1 pair of the 6375 has warped wheels (b)(4).

• Brand Name: PRESSURE TUBING AND ACCESSORIES TO DELIVER PRESSURIZED MEDICAL GASES
• Type of Device: 868.5860
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4087999
• MDR Text Key: 4744537
• Report Number: 1531186-2014-04099
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/13/2014,08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2014
• Distributor Facility Aware Date: 08/21/2014
• Date Report to Manufacturer: 09/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other