MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK UNIVERSAL PROCEDURE TABLE; 630

Model Number	630-021
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On june 10, 2025, midmark corporation was notified of an instance that occurred on or around (b)(6) 2023 in which a model 630 procedure chair fell causing the patient to fall to the ground.Due to the description of event and due diligence, midmark corporation complied with filing this instance.
Additional Manufacturer Narrative
Midmark corporation was made aware on june 10, 2025, of an incident that reportedly occurred on or around (b)(6) 2023, involving a midmark procedure chair.According to the information received, during a medical procedure, a patient was instructed by staff to reposition themselves by turning and lying on their stomach.Upon doing so, the chair allegedly fell flat to the ground, resulting in the patient falling as well.Subsequent evaluation by the patient's primary care provider indicated that the patient sustained a shoulder injury.The incident was not reported to midmark at the time it occurred, and as a result, no prior complaint is on file for the indicated serial number or device.If further information is made available, midmark corporation will comply with a follow up report as necessary.

• Brand Name: MIDMARK UNIVERSAL PROCEDURE TABLE
• Common Device Name: 630
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 22436151
• Report Number: 1523530-2025-00004
• Device Sequence Number: 14600584
• Product Code: GBB
• UDI-Device Identifier: 00841709106514
• UDI-Public: 00841709106514
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 630-021
• Device Catalogue Number: 630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown