inforMED
MalfunctionBWN

T-MAX SHOULDER POSITIONER

Received Sep 7, 2007 · Event occurred Jun 15, 2007

Report 925771 · MDR key 925771

Device

Generic name

Attachment, Shoulder Positioner

Model number

*

Catalog number

*

Lot number

*

Product problems

  • Table collapse
  • Device Issue

Patient

*

  • Abrasion

Narrative

Description of Event or Problem

A PATIENT WAS BEING POSITIONED IN THE OR FOR A RIGHT SHOULDER ARTHROSCOPY USING A T-MAX SHOULDER POSITIONER SUPPLIED FOR TRIAL USE BY A REPRESENTATIVE FROM TENET MEDICAL ENGINEERING COMPANY. PRIOR TO ELEVATING THE SHOULDER POSITIONER PORTION OF THE TABLE, THE STABILITY OF THE TABLE ATTACHMENT WAS CHECKED. WHEN THE EXTENSION WAS RAISED, PART OF THE TABLE COLLAPSED CAUSING THE INTUBATED PATIENT TO SLIP. THE ANESTHESIA AND OR TEAM CAUGHT THE PATIENT AS WELL AS SUPPORTED THE TABLE TO PREVENT IT FROM FALLING. THE SURGERY HAD TO BE POSTPONED AND THE PATIENT WAS EXTUBATED SUCCESSFULLY. THE PATIENT HAD MINOR SKIN ABRASION AS A RESULT OF THE INCIDENT. ONE STAFF MEMBER WHO HELPED SUPPORT THE PATIENT AND TABLE FROM FALLING COMPLETELY IRONICALLY SUSTAINED A SHOULDER INJURY. ANALYSIS OF THE EVENT REVEALED THAT THE CLAMP ON THE EXTENSION FAILED WHEN IT WAS RAISED. PRIOR TO THE FAILURE, THE PROPER PROCEDURES WERE FOLLOWED. THIS DEVICE WILL NOT BE USED FOR FUTURE PROCEDURES.