inforMED
InjuryISD

QUINTON CR60 TREADMILL

Received Apr 14, 2009 · Event occurred Mar 16, 2009

Report 3014398-2009-00014 · MDR key 1363088

Device

Generic name

Rehab Treadmill

Model number

000380-001

Lot number

NA

Product problems

  • Unknown (for use when the device problem is not known)

Patient

Not reported

  • Abrasion
  • Bruise/Contusion
  • Fall
  • Skin Discoloration
  • Hospitalization required

Narrative

Additional Manufacturer Narrative

CUSTOMER REQUESTED FIELD SERVICE ENGINEER (FSE) DISPATCH TO CHECK OUT THE TREADMILL PRIOR TO USING AGAIN. FSE PERFORMED PREVENTATIVE MAINTENANCE WHICH INCLUDED A MECHANICAL AND ELECTRICAL SAFETY CHECK. FSE FOUND NO PROBLEMS WITH THE TREADMILL. DURING HIS INVESTIGATION, THE FSE FOUND THE MAGNETIC KEY FOR EMERGENCY STOPPING WAS ACTIVATED, BUT WAS NOT UTILIZED FOR THE PATIENT. IN ORDER FOR THE KEY TO ASSIST IN EMERGENCY STOPPING, IT MUST BE ENABLED AND ATTACHED TO THE PATIENT.

Description of Event or Problem

IN 2009, CUSTOMER CALLED TO INFORM CARDIAC SCIENCE THAT A PATIENT FELL OFF THEIR TREADMILL WHILE USING IT IN A CARDIAC REHAB SETTING. CUSTOMER STATED THEY DID NOT BELIEVE THE TREADMILL WAS AT FAULT BUT REQUESTED A FIELD SERVICE ENGINEER DISPATCH TO CHECK OUT THE UNIT PRIOR TO USING AGAIN. THE PATIENT FELL OFF THE TREADMILL AND SUSTAINED BRUISING AND SCRAPING TO THE KNEES, LEGS AND FACE WHICH RESULTED IN SOME BLACKENING AROUND THE EYES. THIS PATIENT WAS CHECKED INTO THE EMERGENCY ROOM TO BE EVALUATED. IT WAS SUGGESTED THAT HER FALL MAY HAVE BEEN THE RESULT OF A BLACK OUT.