MAUDE Adverse Event Report: WESTERN MEDICA / SCOTT FETZER COMPANY MEDICA CARBON DIOXIDE REGULATOR; REGULATOR, PRESSURE, GAS CYLINDER

Model Number M1-940-PG

Device Problem Defective Component (2292)

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

Event Date 02/09/2020

Event Type  malfunction  

Event Description

When changing circuit, elevated co2 noted, and would not come down until co2 regulator was changed.Medica carbon dioxide regulator.Equipment removed from ecmo pump and replaced with another regulator.Infant had a scheduled head ultrasound after the incident which showed no change.

• Brand Name: MEDICA CARBON DIOXIDE REGULATOR
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): WESTERN MEDICA / SCOTT FETZER COMPANY; 875 bassett rd; westlake OH 44145
• MDR Report Key: 10020241
• MDR Text Key: 189735062
• Report Number: 10020241
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M1-940-PG
• Device Catalogue Number: M1-940-PG
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2020
• Type of Device Usage: N
• Patient Sequence Number: 1