Universal frame 100724A1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046768121553), received between Apr 11, 2024 and Apr 11, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2024Positioning Failure; Difficult to Open or Close; Positioning Failure; Difficult to Open or Close

  ON 19TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES - 100724A1 - UNIVERSAL FRAME, EU. AS IT WAS STATED, THE REINFORCEMENT BRACKET SCREW WAS BLOCKED DURING POSITIONING OF THE PATIENT IN PREPARATION FOR NEUROSURGERY ON THE ANESTHETIZED PATIENT. THE ISSUE LED TO A DELAY IN STARTING THE OPERATION DUE TO CHANGING OF THE OPERATION PLAN. BASED ON THE INFORMATION PROVIDED BY THE GETINGE TECHNICIAN FOLLOWING SERVICE VISIT ON SITE, THE REINFORCEMENT SYSTEM LOCKING/UNLOCKING KNOB WAS FOUND TO BE COMPLETELY UNSCREWED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085812 ↗