MalfunctionINW
ERGOSTYLE FX WITH MANUAL DROPS
Received Jan 30, 2009
Report 1022819-2009-00021 · MDR key 1343363
Device
Product problems
- Break
- Burst Container or Vessel
- Failure to Shut Off
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE CLINICIAN WAS LOWERING THE TABLE SURFACE WITH THE PATIENT ON THE TABLE SURFACE WHEN THE MOTOR MALFUNCTIONED. THE TABLE REACHED FULL RETRACTION AND THE MOTOR CONTINUED TO ATTEMPTING TO LOWER THE TABLE SURFACE. THIS ACTION CAUSED THE UPPER YOKE WHERE THE MOTOR IS SECURED TO FLEX. THE FLEX MOTION BROKE THE CASTING OF THE ACTUATOR. THE BROKEN PIECE OF CASTING DID EJECT FROM UNDER THE TABLE.
Additional Manufacturer Narrative
AWAITING DEVICE RETURN AND EVALUATION. ONCE THE DEVICE IS RETURNED AND EVALUATED, A CONCLUDING FORM 3500A WILL BE SENT TO THE FDA-MDR.