MAUDE Adverse Event Report: DYNAMIC CONTROLS ANALYZER, GAS, OXYGEN, GASEOUS-PHASE; 868.1720

Model Number IRC400

Device Problem Failure to Analyze Signal (1539)

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

Event Type  malfunction  

Event Description

Per the dealer, the unit will not analyze.

Manufacturer Narrative

(b)(4).Upon further review, it was determined that the initial report submitted on 08/01/2014 for manufacturer report # 9613440-2014-00001 was not a reportable event.This product, an irc400 hand held analyzer, is not a medical device.It is a technician's tool for oxygen concentrators to check the oxygen concentration, flow rate and outlet pressure.No mdr needed to be filed.

• Brand Name: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Type of Device: 868.1720
• Manufacturer (Section D): DYNAMIC CONTROLS; 17 print place; christchurch 8002 ; NZ 8002
• Manufacturer (Section G): DYNAMIC CONTROLS; 17 print place; christchurch 8002 ; NZ 8002
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3973373
• MDR Text Key: 4637163
• Report Number: 9613440-2014-00001
• Device Sequence Number: 1
• Product Code: CCL
• 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,Followup
• Report Date: 06/13/2014

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: Lay User/Patient
• Device Model Number: IRC400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2014
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other