MAUDE Adverse Event Report: MEDICAL GRAPHICS CORP. REG O2 135PSI 3/8 TUBING CGA 540; REGULATOR, PRESSURE, GAS CYLINDER

Model Number 545012-002 REV F

Device Problems Use of Incorrect Control/Treatment Settings (1126); Fire (1245); Connection Problem (2900); Explosion (4006)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 04/27/2022

Event Type  Injury  

Event Description

Respiratory therapy (rt) employee received 1st and 2nd degree burns when an oxygen (o2) regulator caught fire in the pulmonary function testing (pft) lab.The o2 regulator exploded (burst) when the rt employee turned on the o2 tank valve connected to the o2 regulator.This o2 regulator was connected both to the o2 tank and the pft medical device system.The rt employee was directly in front of both the o2 tank and o2 regulator when the flash fire started.Fire was put out by a nearby x-ray technician (employee).Rt employee received burns to face, torso, arm, and hand.Rt employee was taken to a local hospital and then subsequently transferred to burn unit.Biomedical engineering, along with respiratory therapy and pft manufacturer representative, investigated the incident site day after incident.Additional photos were taken of the incident site.The o2 regulator chassis was severely compromised and burned.The pft manufacturer and biomedical engineering noticed an issue with the o2 regulator.The low pressure side of the o2 regulator was connected to the high pressure o2 tank source.Biomedical engineering compared a photo of the regulator setups (taken the day before the incident) to photos of the failed regulator.The o2 regulator configuration was not the same.It was determined that the o2 regulator that failed had the incorrect side of the regulator connected to the o2 source.It was determined that the incorrect inlet fitting was connected to the low pressure side of the failed o2 regulator.It was determined the o2 regulator had the correct configuration in the photo taken prior to the incident, but had a different, incorrect configuration at the time of incident.The o2 regulator assembly in use was supplied by the manufacturer for exclusive use with the manufacturer's pft medical device system.

• Brand Name: REG O2 135PSI 3/8 TUBING CGA 540
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): MEDICAL GRAPHICS CORP.; 350 oak grove pkwy.; saint paul MN 55127
• MDR Report Key: 14564300
• MDR Text Key: 293080975
• Report Number: 14564300
• 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: 05/17/2022,05/13/2022

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?: Yes
• Device Operator: Other
• Device Model Number: 545012-002 REV F
• 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: 05/17/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization