MAUDE Adverse Event Report: AMVEX CORPORATION AMVEX INTEGRATED FLOWMETER

Model Number FI-C15UO-DD-B

Device Problems Failure to Deliver (2338); No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

An occurence was reported to mfg amvex corporation on (b)(6) 2015 regarding an incident that occured on (b)(6) 2015 in which fm dial was positioned between 10 and 15 and no oxygen was delivered.Device functioned as designed.When dialed between numbers, oxygen flow will not be achieved.User facility was contacted via telephone and user error was confirmed.While no serious injury was reported to the manufacturer this event is being reported due to the potential for serious injury should a user not heed to the warning listed "warning: there is no flow between settings." listed in important safety instructions on page 2 on product manual, and stated on page 3 under intended use.Device operating as designed.User error.

Event Description

An intubated patient was being transferred to a different room in the unit.During the transfer, the patient was being "bagged" via ambu bag.When the ambu bag was connected to the wall in the new room, the respiratory therapist turned the oxygen flow dial to a position she thought was 15 liters.While looking at the reservoir bag attached to the ambu, she noticed it was not inflating.They immediately moved the tubing to another oxygen delivery nozzle in the room and turned it up to 15 liters with immediate inflation of the bag indicating appropriate delivery.Upon investigation, the nurse identified that the dial was positioned between the 10 and the 15 and was delivering no oxygen.This patient, due to the delay in therapy, suffered a severe drop in her oxygen saturation and took hours and creative ventilator management to recover.

• Brand Name: AMVEX INTEGRATED FLOWMETER
• Type of Device: INTEGRATED FLOWMETER
• Manufacturer (Section D): AMVEX CORPORATION; 25b east pierce st; richmond hill; ontario L4B 2 M9; CA L4B 2M9
• Manufacturer (Section G): AMVEX CORPORATION; 25b east pierce st; richmond hill; toronto L4B 2 M9; CA L4B 2M9
• Manufacturer Contact: charmaine penney ; 25b east pierce st; richmond hill; toronto L4B 2-M9 ; CA L4B 2M9 ; 7647736
• MDR Report Key: 5262975
• MDR Text Key: 32591215
• Report Number: 9617620-2015-00001
• Device Sequence Number: 1
• Product Code: CCN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FI-C15UO-DD-B
• Device Catalogue Number: FI-C15UO-DD-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 12/03/2015
• 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: 1 HR