Modular universal table top 115030D0Recalls & reported problems
MAQUET GmbH · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046768003354), received between Feb 26, 2024 and Feb 7, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Difficult to Open or Close2
- Unintended Movement2
- Crack1
- Fracture1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Abrasion1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2025Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR DEVICES - 115030D0 - MODULAR UNIVERSAL TABLE TOP, USED WITH 115031D0 - STANDARD BACK PLATE AND 113064G0 - HEAD REST. DURING THE PREPARATION FOR SPINAL FIXATION SURGERY THE PATIENT WAS TRANSFERRED FROM THE STRETCHER TO THE OPERATING TABLE IN A PRONE POSITION. THE PATIENT'S BODY WAS SHIFTED TOWARD THE HEAD SIDE TO ADJUST THE POSITION. AT THIS MOMENT, THE CLAMP OF THE OPERATING TABLE'S CHEST SECTION SUDDENLY BROKE AND FELL, DESPITE BEING LOCKED. THIS CAUSED THE PATIENT TO SUDDENLY FALL TOWARD THE HEAD SIDE OF THE TABLE. THE MEDICAL TEAM QUICKLY INTERVENED AND SUPPORTED THE PATIENT, PREVENTING ANY HEAD INJURY. SINCE THE BREATHING CIRCUIT HAD NOT YET BEEN CONNECTED, THERE WAS NO ACCIDENTAL REMOVAL OF THE INTUBATION TUBE. THE PATIENT WAS THEN TRANSFERRED BACK TO THE STRETCHER TO ENSURE SAFETY. AS VITAL SIGNS REMAINED STABLE THROUGHOUT THE INCIDENT, THE SURGERY WAS PERFORMED AFTER THE TABLE WAS REPLACED AND ANESTHESIA WAS ADMINISTERED. DUE TO THE FALL, THE PATIENT SUFFERED A MINOR 1 CM ABRASION ON THE RIGHT ARM. NO OTHER INJURIES OR ABNORMALITIES WERE OBSERVED DURING A FULL-BODY VISUAL INSPECTION, AND POST-OPERATIVE X-RAYS CONFIRMED NO FRAC
Patient problems: Abrasion
MAUDE report 21332018 ↗MalfunctionApr 30, 2024Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement
ON 22ND APRIL 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 115030D0 - MODULAR UNIVERSAL TABLE TOP. AS IT WAS STATED, THE UPPER BACK PLATE FOLDED DOWN WITH THE PATIENT ON THE TABLE TOP DURING THE OPERATION. FORTUNATELY, THE STAFF WAS ABLE TO CATCH THE PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED MOVEMENT OF THE TABLE CREATING A RISK OF NERVE OVERSTRETCHING OR THE PATIENT¿S FALL, WAS TO REOCCUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212277 ↗MalfunctionFeb 26, 2024Crack; Fracture; Use of Device Problem; Crack; Fracture; Use of Device Problem
ON 13TH FEBRUARY 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS ¿ 115030D0 - MODULAR UNIVERSAL TABLE TOP. AS IT WAS STATED, THE CUSTOMER DROVE ONTO AN EQUIPMENT TROLLEY BREAKING CENTRAL HOUSING WHILE THE PATIENT WAS LYING ON THE OPERATING TABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY BROKEN CENTRAL HOUSING WHICH COULD CAUSE UNINTENDED MOVEMENT OF THE TABLE TOP AND CREATE A RISK OF PATIENT'S FALL, WAS TO REOCCUR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18775774 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.