MAUDE Adverse Event Report: INOVO, INC. BASIC CLICK STYLE REGULATOR; OXYGEN REGULATOR

Model Number OM4815-L-BLUE

Device Problems Use of Device Problem (1670); No Flow (2991)

Patient Problems Anoxia (1711); Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Brain Injury (2219)

Event Date 02/16/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, received call from (b)(6).He stated that a patient was using part no om-4815-l-blue and the dial was dialed in between the numbers.Per (b)(6), the patient was not receiving oxygen while the unit was between selector flow settings.As a result he had an anoxic brain injury.This resulted in a cardiac arrest and the patient was sent to the hospital.He was on life support but he has since been discharged.On (b)(6) 2015, received another call from (b)(6) and he explained that what happened was that the patient was already in the hospital and just had surgery.It was the operating room that was using the regulator which was between flow settings when the situation happened.Per (b)(6), the nurse did not sequester the unit so they have no way of knowing which unit it was.(b)(6) also said that they began coding (cpr) the patient on (b)(6) 2015.This happened around 23:48pm on the (b)(6) because the patient arrested in enroute to the recovery room.(b)(4)also advised that the anesthesiologist set the regulator but it was between 2 flows and they did not know.Per (b)(6), the original setting was 8lpm.(b)(6) mentioned that the patient was taken off the anesthesia machine and placed on a portable tank with a regulator.This was done in the operating room before transport to the recovery room.Finally they recognized when they got to the recovery room that his breathing had stopped and further checking the heart was not pumping and they started cpr.

Manufacturer Narrative

On (b)(6), spoke with (b)(6).He told me that a (b)(6) male patient was post operative, and physician thought he set oxygen flow on the 48155 model regulator to 8lpm.At some point later, they had determined that the patient was not getting enough oxygen flow and that the flow meter was set between 2 settings.I'd asked him for the serial #, but said that the unit had been put back into circulation.He said that he checked other units of the same model and could duplicate the "no flow between settings" behavior.I informed (b)(6) that this was not a product failure, but that this is the way all click style regulators operate; ours and every other company that we are familiar with, and this is not a product failure, but rather a method of operation.

• Brand Name: BASIC CLICK STYLE REGULATOR
• Type of Device: OXYGEN REGULATOR
• Manufacturer (Section D): INOVO, INC.; 401 leonard blvd n; lehigh acres FL 33971
• Manufacturer Contact: mike dildine ; 401 leonard blvd n; lehigh acres, FL 33971 ; 2396436577
• MDR Report Key: 4643650
• MDR Text Key: 5612398
• Report Number: 1062191-2015-00001
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OM4815-L-BLUE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR