inforMED
MalfunctionILJ

SITZ BATH 1616700692

Received Jan 12, 2016

Report 1219590-2016-00004 · MDR key 5359646

Device

Generic name

Bath, Sitz, Nonpowered

Model number

IH3800

Product problems

  • Detachment Of Device Component
  • Device Operates Differently Than Expected
  • Difficult to Open or Close

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

Description of Event or Problem

CUSTOMER NEEDS A REPLACEMENT DOOR SEAL SENT OUT UNDER THE LIFETIME WARRANTY. SEAL IS COMING APART FROM THE DOOR AND THE DOOR WILL NOT CLOSE TIGHTLY ENOUGH TO FILL WITH WATER.

Remedial action

  • Replace