FDA Adverse Event Death Summary report: N

*

MDR report key: 168302 · Received May 20, 1998

Report

Report Number
168302
Event Type
Death
Date Received
May 20, 1998
Date of Event
April 20, 1998
Report Date
May 20, 1998
Manufacturer
VESS CHAIRS, INC.
Product Code
FRK
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
WI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON APRIL 20, A PT WAS IN 4TH FLOOR, A-WING, SEATED IN A SPECIAL CHAIR USED FOR SWALLOWING STUDIES. AN E-SIZED OXYGEN TANK WAS MOUNTED IN A BOX ON THE BACK OF THE CHAIR. THE BOX CAME LOOSE, SWINGING SIDEWAYS, AND THE REGULATOR ON THE TOP OF THE OXYGEN CYLINDER PULLED ON AN IV LINE GOING TO THE PT. THE CHAIR WAS PURCHASED IN 1992. IT IS A SPECIAL CHAIR WITH ADAPTIVE SEATING, FOR MODIFIED BARIUM SWALLOW IMAGING STUDIES. THE CHAIR IS RADIOPARENT, TO ALLOW X-RAYS TO PENETRATE THE CHAIR. IT COMES FROM VESS WITH A REMOVABLE BOX THAT FITS ON THE BACK OF THE CHAIR TO HOLD A OXYGEN TANK. THE CHAIR HAS 3 RIVETS ON THE BACK, THAT ARE USED TO SUPPORT THE REMOVABLE OXYGEN TANK HOLDER. THE RIVETS HAVE A HEAD THAT IS 5/8" DIAMETER, AND A SHAFT THAT IS 3/8" DIAMETER. THE TOP TWO RIVETS ARE 13" OFF THE FLOOR, AND THE THIRD ONE IS CENTERED BELOW THE OTHER TWO, ABOUT 7" ABOVE THE FLOOR. ALL 3 RIVETS ARE IN THE SAME VERTICAL PLANE. THE RIVETS ALL APPEARED IN GOOD CONDITION. THERE IS NO OBVIOUS PROBLEM WITH THE CHAIR. THERE IS A BLACK PLASTIC BOX THAT FITS ON THE BACK OF THE CHAIR. TO MOUNT THE BOX, THERE ARE 3 SLOTS WHICH FIT OVER THE 3 RIVET HEADS, THEN THE BOX SLIDES DOWN ABOUT 1/2" UNTIL THE NARROW PART OF THE SLOTS CATCH ON THE RIVET SHAFTS. THERE WAS A PROBLEM WITH THE BOX. THE BOX IS MADE WITH A SEAM THROUGH THE CENTER-LINE OF THE CENTER RIVET SLOT. ONE OF THE NYLON RIVETS HOLDING THE BOX TOGETHER WAS MISSING, AND THE SEAM WAS UNEVEN. ALL DIRECTIONS AND ORIENTATIONS IN THIS REPORT ARE AS SEEN BY A PERSON STANDING BEHIND THE CHAIR, LOOKING AT THE BOX MOUNTED ON THE BACK OF THE CHAIR. THE PANEL ON THE RIGHT WAS BENT INWARDS, SO THAT THE BOTTOM SLOT WOULD LIKELY NOT STRADDLE THE CENTER RIVET ON THE CHAIR. THE BOX WOULD LIKELY ONLY REST AGAINST THE CENTER RIVET FROM THE LEFT SIDE. THERE ARE SCRATCH MARKS ON THE BACK PANELS, WHICH APPEAR TO HAVE BEEN MADE BY THE CENTER RIVET. THE DEEPEST SCRATCH SWINGS UP IN AN ARC ALONG THE SECURE PANEL ON THE LEFT SIDE. THE CTR OF THE RADIUS OF THE ARC IS AT THE RIGHT RIVET. IT APPEARS AS THOUGH THE BOX WAS SUPPORTED ONLY BY THE RIGHT RIVET. HOWEVER, WITNESSES SAID THE BOX WAS TIPPED THE OTHER DIRECTION, AS THOUGH IT WAS SUPPORTED ONLY BY THE LEFT RIVET. LOOKING MORE CLOSELY AT THE BACK OF THE BOX SHOWS A SCRATCH MARK FROM THE BOTTOM SLOT, THAT WOULD INDICATE THE BOX HAD ALSO SWUNG CLOCKWISE FROM THE LEFT RIVET. TAPPING THE BOX CAN KNOCK IT LOOSE. WITNESSES ACCOUNT THAT THE BOX HAD SWUNG CLOCKWISE, WITH THE OXYGEN CYLINDER SIDEWAYS, ALMOST FALLING OUT OF THE BOX, LEANING TO THE RIGHT. THIS WOULD MEAN THE BOX WAS SUPPORTED ONLY BY THE TOP LEFT RIVET. THE BOX CAME OFF THE CENTER RIVET, AND OFF OF THE RIGHT RIVET. THE OXYGEN REGULATOR AT THE TOP OF THE TANK CAUGHT SOME TUBING, AND PULLED IT. THE TUBING WAS DRAPED FROM AN IV POLE TO A CATHETER-INTRODUCER AND INTRA-JUGULAR LINE ON THE PT. IT WAS A 3-PORT LINE WITH TOTAL PARENTERAL NUTRITION, LIPIDS, AND IV SOLUTIONS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * RADIOPARENT CHAIR FRK VESS CHAIRS, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 * Death