MAUDE Adverse Event Report: OHIO MEDICAL AMVEX FLOWMETER

Lot Number FMAC 2946960

Device Problems Detachment Of Device Component (1104); Inaccurate Delivery (2339); Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 01/29/2018

Event Type  Death  

Event Description

Hospice patient was placed on 70 percent fio2 via t-piece delivered at 15 l/min.Oxygen tubing was witnessed by nursing staff to pop off at venturi connection.This was replaced by staff.Patient was found with t-piece on chest and o2 disconnected from flow meter.Indicator ball noted to be floating at top of meter.Patient expired.Nurse, upon finding patient, reconnected oxygen and during assessment of patient for any vital signs, tubing again dislodged from flow meter.Flow meter was tested by biomedical department and found it to be delivering oxygen outside of manufacturer specification.At 15 l, the flow meter was delivering 20.14 l/min.Utilizing a different oxygen set up mirroring the patient set up in a controlled biomed environment, tubing connected to this flow meter again popped off at the venturi connection at 10 minutes of flow, and once replaced, regulator ball was witnessed to drift to the top of regulator.Once tubing replaced, the system popped off the tubing again at 20 minutes of flow.Ref mfr # 1419185-2018-00001.

• Brand Name: AMVEX FLOWMETER
• Type of Device: AMVEX FLOWMETER
• Manufacturer (Section D): OHIO MEDICAL; 1111 lakeside drive; gurnee IL 60031
• MDR Report Key: 7263180
• MDR Text Key: 99899326
• Report Number: 7263180
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: FMAC 2946960
• 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: 02/02/2018
• Distributor Facility Aware Date: 01/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 52