MAUDE Adverse Event Report: MEDICAL GRAPHICS CORPORATION PLATINUM ELITE DX; BODY PLETHYSMOGRAPH

Model Number	830008-902
Medical Device Problem Codes	Misassembly by Users (3133); Explosion (4006)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Chief of respiratory care reported to the manufacturer's representative that an employee had disconnected the compressed gas regulators while moving the gas cylinders within the testing laboratory.When the employee reconnected the regulators and turned on the 100% oxygen, the regulator exploded and a 2-3 foot long flame emerged from the regulator body.The employee received first and second degree burns to the face, torso, arm, and hand and was taken to the hospital for treatment.The fire was extinguished by another employee.No patients were present or injured during the incident.
Additional Manufacturer Narrative
Mgc sales consultant visited the site the day after the incident and interviewed personnel and took photographs.Production manager identified that the regulators for both o2 and dlco were inverted (inlet and outlet fittings were reversed on the regulator).Mgc qara and operations identified the work order the regulator was assembled and traced all shipments from that work order.Technical support and service contacted all customers who had regulators assembled on that work order and confirmed the regulators deployed to the field were assembled correctly.In subsequent discussions with va biomedical engineering and chief of rt, it was determined that a respiratory tech (not biomedical engineering) was tasked with moving the gas tanks from a temporary cart to the permanent chain-up station in the laboratory space.Va biomedical engineer provided mgc a photograph showing the o2 tank/ regulator set-up the day before the incident in which the o2 regulator was correctly assembled.This is in agreement with the field service/ training records of mgc personnel on-site installing and servicing the platinum elite.Additional photographs show the orientation of the tanks/ regulators in the permanent chain-up station in the manufacturer assembled condition would have resulted in the tubing coming off the regulator running directly into a wall.From this investigation, we have concluded that the end-user used a tool to intentionally modify the regulators by inverting the inlet and outlet fittings.This action is in disagreement with the labeled stamps on the regulator body identifying high pressure (hp) and low pressure (lp) sides of the regulator.When the regulator was affixed to the 100% o2 tank and the valve was opened, full tank pressure (2000 psi) was delivered to the low pressure side of the regulator (set to deliver 135 psi).This high pressure applied to the wrong (low pressure) side of the regulator led to the catastrophic failure of the regulator, explosion, fire, and injury to user.The failed regulator was in the custody of the va clinic until they provided it upon request to osha for additional evaluation.Photographs are in section "file attachments".

• Brand Name: PLATINUM ELITE DX
• Common Device Name: BODY PLETHYSMOGRAPH
• Manufacturer (Section D): MEDICAL GRAPHICS CORPORATION; 350 oak grove parkway; st. paul MN 55127 8599
• Manufacturer (Section G): MEDICAL GRAPHICS CORPORATION; 350 oak grove parkway; st. paul MN 55127
• Manufacturer Contact: james mcgurran ; 350 oak grove parkway; st. paul, MN 55127 ; 6517663495
• MDR Report Key: 16566090
• Report Number: 2183022-2022-01002
• Device Sequence Number: 5561243
• Product Code: CCM
• UDI-Device Identifier: 00810016250241
• UDI-Public: 010081001625024111220105
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K943259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: 830008-902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REGULATOR O2 135 PSI 3/8 TUBING CGA 5400.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Unknown