inforMED

MATTRESS COVER FOR MEDICAL PURPOSES

Received Aug 15, 2012

Report 1531186-2012-00704 · MDR key 2700977

Device

Generic name

880.6190

Model number

CG9701

Product problems

  • Product Quality Problem

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

(B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL CG9701, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1074240 REV(1) 7/98 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S 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 CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. NO MALFUNCTION VERIFIED.

Description of Event or Problem

DEALER STATES: THE UNIT IS NOT FILLING COMPLETELY."