MAUDE Adverse Event Report: DEL MEDICAL EV800 ELEVATING TABLE WITH FOUR -WAY FLOAT TOP; ELEVATING RADIOGRAPHIC TABLE

Model Number	EV800
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the image provided by the customer, the chain on one end of the sprocket assembly appeared loose.Combined with the presence of metal shavings, this indicates that the sprocket on the tension assembly shaft was worn and grinding against the tensioner.This wear likely caused the driver to loosen, resulting in the teeth skipping on one side and the table to tilt.Ts provided the following part numbers: bar weldment-sprocket adjust 114-0208g1.Sprocket assembly, 11 tooth 112-0262g1.The dhr for the table was reviewed and it shows that the table was found to be compliant prior to leaving del medical.Line number 25 of the ev800 inspection form (mf 10.80) specifically calls for verifying the master link was secured and that the chain had proper tension.The probability of occurrence of harm for all ras associated to this complaint is 1 - negligible, as defined in internal standard operating procedures.
Event or Problem Description
On (b)(6) 2026, the customer contacted ts to report that the ev 800 tabletop (serial number (b)(6)) tilted while a patient was on it.The customer confirmed that no injuries occurred as a result of the incident.Pictures from the customer showed the sprocket adjust worn and metal shavings underneath the tabletop, in a cavity not accessible to the patient or user.

• Brand Name: EV800 ELEVATING TABLE WITH FOUR -WAY FLOAT TOP
• Common Device Name: ELEVATING RADIOGRAPHIC TABLE
• Manufacturer (Section D): DEL MEDICAL; 241 covington drive; bloomingdale IL 60108
• Manufacturer (Section G): DEL MEDICAL; 241 covington drive; bloomingdale IL 60108
• Manufacturer Contact: george bell ; 241 covington drive; bloomingdale, IL 60108 ; 8008006006
• MDR Report Key: 24972127
• Report Number: 0001418964-2026-00002
• Device Sequence Number: 18786808
• Product Code: IZZ
• UDI-Device Identifier: 00858340006028
• UDI-Public: (01)00858340006028
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: EV800
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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 Sex: Unknown