MAUDE Adverse Event Report: TENACORE HOLDINGS, INC.; OXYGEN FLOW METER

Model Number TOFM

Device Problem Material Fragmentation (1261)

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

Event Date 09/29/2015

Event Type  malfunction  

Event Description

This is more of a chronic failure not specific to a patient or one device.The flow meters that we have gotten from tenacore seem to have a weak inner tube where the flow ball indicator resides.The top of this tube constantly breaks into small pieces which could compromise the flow indicator.Manufacturer response for o2 flow meter, flow meter (per site reporter): they are working with their distributor to make this device better.

• Type of Device: OXYGEN FLOW METER
• Manufacturer (Section D): TENACORE HOLDINGS, INC.; 1525 east edinger ave; santa ana CA 92705
• MDR Report Key: 5129680
• MDR Text Key: 27557388
• Report Number: 5129680
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: TOFM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO