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U.S. Department of Health and Human Services

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

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MEDICAL GRAPHICS CORP. REG O2 135PSI 3/8 TUBING CGA 540; REGULATOR, PRESSURE, GAS CYLINDER Back to Search Results
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.
 
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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 Key14564300
MDR Text Key293080975
Report Number14564300
Device Sequence Number1
Product Code CAN
Combination Product (y/n)N
Number of Events Reported1
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 Number545012-002 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 FDA05/17/2022
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer06/01/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/01/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention; Hospitalization;
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