inforMED
MalfunctionILZ

DAILY ACTIVITY ASSIST DEVICES

Received Nov 22, 2011

Report 9616091-2011-00120 · MDR key 2344910

Device

Generic name

890.5050

Manufacturer

Invamex

Model number

9630-4

Product problems

  • Crack

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THE SEAT ON THE COMMODE IS ALLEGEDLY CRACKED. NO INJURY IS ALLEGED.

Additional Manufacturer Narrative

NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9630-4, SERIAL NUMBER/DATE CODE IS UNKNOWN. THE USER MANUAL PART NUMBER 1148075 WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.