CHEST SUPPORT SECTION ASSY. 5840-580Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842430104343), received between Feb 19, 2020 and Nov 11, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021Crack; Crack

  DURING PRE/POST-PROCEDURE INSPECTION, THE CHEST TRAY WAS FOUND TO HAVE A CRACK. UNKNOWN HOW OR WHEN THE CRACK HAPPENED, BUT THERE IS SUSPICION IT MIGHT HAVE BEEN WHEN THE PREVIOUS PATIENT WAS ON THE TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801195 ↗
• MalfunctionJul 13, 2021Fracture; Fracture

  ADULT FEMALE TO OPERATING ROOM FOR TREATMENT OF T12 BURST FRACTURE SUSTAINED STATUS POST A FALL OUT OF BED A WEEK EARLIER. PLANNED PROCEDURE WAS OPEN TREATMENT, REDUCTION, AND KYPHOPLASTY T12 WITH TLL-LL POSTEROLATERAL BONE FUSION AND PEDICLE SCREW INSTRUMENTATION. PATIENT IS MORBIDLY OBESE, WT: 290 LB, BMI: 50. PATIENT WAS POSITIONED PRONE FOR SURGERY ON TRIOS TABLE AT 1351. AT 1358 A LOUD CRACK WAS HEARD AND THE PATIENT WAS NOTED TO HAVE SETTLED INTO THE TABLE FRAME. THE CHEST SUPPORT ON THE TABLE HAD CRACKED AND COMPLETELY FALLEN OFF. THE PATIENT WAS RESTING ON THE TWO RAILS OF THE TABLE, SUPPORTED BY HER BODY AND SHOULDERS. THERE WAS NO OBVIOUS HYPEREXTENSION, MALALIGNMENT, OR INJURY NOTED. THE INCISION WAS QUICKLY CLOSED AND THE PATIENT WAS TURNED SUPINE ONTO A STRETCHER AT 1400. A REPLACEMENT CHEST SUPPORT WAS OBTAINED AND THE PATIENT WAS REPOSITIONED PRONE AT 1404. THE PATIENT WAS THEN RE-PREPPED AND RE-DRAPED AND SURGERY PROCEEDED AS PLANNED. NO OBVIOUS INJURIES WERE NOTED UPON RETURNING THE PATIENT TO THE SUPINE POSITION POST-OP. NO ADDITIONAL DIAGNOSTIC IMAGING WAS OBTAINED RELATED TO THIS INCIDENT. THE WEIGHT LIMIT OF THE TRIOS TABLE IS 600LBS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159320 ↗
• MalfunctionApr 8, 2021Crack; Crack

  IT WAS REPORTED THAT THE CUSTOMER HAS FOUND A CRACK THAT HAS FORMED ON THEIR CHEST SUPPORT SECTION ASSEMBLY NEAR THE CORNER OF THE PLATE PORTION OF THE ASSEMBLY. INVESTIGATION FOUND THE TRAY WAS MOST LIKELY DROPPED ON ONE CORNER, CAUSING THE MATERIAL TO CRACK IN THAT AREA. THE CRACK WOULD BE SEEN ON INSPECTION, AS REQUIRED BEFORE USE. BUT IF THE USER FAILED TO INSPECT THE TRAY AFTER DROPPING IT AND BEFORE USING IT, THE CRACK COULD BE HIDDEN UNDER THE PAD AND, AS THE CRACK GOES THROUGH THE MATERIAL, THE TRAY COULD BREAK UNDER THE WEIGHT OF A PATIENT. BECAUSE A BROKEN TRAY WAS ONCE REPORTED TO HAVE CONTRIBUTED TO A PATIENT INJURY, THE CHANCE OF RECURRENCE IS NOT CONSIDERED REMOTE AND THEREFORE THIS DAMAGE IS BEING REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633381 ↗
• MalfunctionMar 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE CHEST SUPPORT ASSEMBLY BROKE WITH A PATIENT ON THE TABLE. PATIENT WAS NOT INJURED. BREAK WAS AT TOP OF THE SIDE WALLS ON BOTH SIDES WHERE IT STARTS THE ATTACHMENT OVER THE TABLE RAILS. VELCRO TO SECURE TO THE TABLETOP WAS MISSING ON BOTH SIDES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9811120 ↗
• MalfunctionFeb 19, 2020Break; Break

  PATIENT WAS TRANSFERRED OFF OF THE TABLE AND THE STAFF NOTICED THE BROKEN PAD BASE. IT WAS FOUND THE MIZUHO OSI CHEST PAD AND SUPPORT PLATE WERE BEING USED ON AN ALLEN SPINE FRAME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9728878 ↗