inforMED
MalfunctionGDC

OSI FLAT TOP BED

Received Feb 15, 2017 · Event occurred Sep 21, 2016

Report 6331514 · MDR key 6331514

Device

Generic name

Table, Operating-room, Electrical

Lot number

9655

Product problems

  • Unintended System Motion
  • Device Slipped
  • Torn Material

Patient

69 YR

  • No Information
  • No Information

Narrative

Description of Event or Problem

PATIENT POSITIONED PRONE, SAFETY STRAPS PLACED ON PATIENT. SURGEON REQUESTED TO TILT PATIENT A SMALL DEGREE. BED LIGHTS INDICATED THAT ROTATION WAS SAFE TO PROCEED. WHEN THE REMOTE WAS TOUCHED, BED WENT INTO FREE ROTATION AND WENT TO A 90 DEGREE POSITION TO THE FLOOR ON ITS OWN. THE GEARS JUST GAVE AWAY, REQUIRING THE NURSE, PHYSICIAN AND REP TO HOLD THE BED IN A PRONE PATIENT POSITION UNTIL HELP ARRIVED. NO PATIENT INJURY. UPON ARRIVAL IN BIOMED, BED WAS CONNECTED AND FOUND POWER ENTRY MODULE LOOSE, SPLASH GUARD TORN ON ON/OFF SWITCH, HEAD END CASTER RIGHT SIDE DEMONSTRATED WIGGLE. BED FAILED 5-3 ABLE TO MOVE CROSSBAR WHEN LAMP IS ON, 5-5- FAILED 95 FR CHECK. THIS BED WAS RECENTLY NEW AND STILL UNDER WARRANTY. FIRST PREVENTATIVE MAINTENANCE DUE LATER THIS YEAR.