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

Model Number	830008-902
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received indicating that a patient undergoing pulmonary function testing became temporarily trapped inside the body plethysmograph chamber of a platinum elite dx system.During testing, the door seal remained inflated and did not deflate as intended when the door release mechanisms were activated.Attempts by clinical staff to open the chamber door were unsuccessful because the inflatable door seal remained fully pressurized.A biomedical technician attempted several mitigation actions, including removing electrical power from the system, removing the lower trigger switch, activating the emergency panic button, pressing the deflate control, and depressurizing the gas supply.Despite these actions, the door seal remained inflated.As a result, the staff ultimately cut the door seal in order to allow the patient to exit the chamber.The patient was released after approximately 20 minutes in the body box.

• Brand Name: BODY PLETHSMOGRAPH
• Common Device Name: PLATINUM ELITE DX
• 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 8599
• Manufacturer Contact: james mcgurran ; 350 oak grove parkway; st. paul, MN 55127-8599 ; 6517663495
• MDR Report Key: 24630510
• Report Number: 2183022-2026-00001
• Device Sequence Number: 8958281
• Product Code: CCM
• UDI-Device Identifier: 00810016250241
• UDI-Public: (01)00810016250241(11)230124
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 830008-902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White