MAUDE Adverse Event Report: CARESTREAM MEDICAL INTERNATIONAL LTD PRO-NOX; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number CMI-0100-PNX-HS

Device Problem Protective Measures Problem (3015)

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

Event Date 08/09/2019

Event Type  malfunction  

Event Description

Recent institution of the use of nitrous oxide (no) for laboring mothers was followed by badge testing to measure the amounts of no in 2 areas on the patient room and the exposure to the nurse attending to the patient.An independent report was received indicating that 7 of 18 readings exceeded national institute for occupational safety and health (niosh) recommendations of 25ppm of no over the duration of the exposure.The program was suspended the following day.It is not currently known if the equipment used contributed to these exposures.

• Brand Name: PRO-NOX
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CARESTREAM MEDICAL INTERNATIONAL LTD; 774 s northlake blvd; altamonte springs FL 32701
• MDR Report Key: 8964424
• MDR Text Key: 156627275
• Report Number: 8964424
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CMI-0100-PNX-HS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1