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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE CLEVELAND STREET SITZ BATH 1616700692; BATH, SITZ, NONPOWERED
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INVACARE CLEVELAND STREET SITZ BATH 1616700692; BATH, SITZ, NONPOWERED Back to Search Results
Model Number IH3800
Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available, a supplemental record will be filed.
 
Event Description
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.
 
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Brand Name
SITZ BATH 1616700692
Type of Device
BATH, SITZ, NONPOWERED
Manufacturer (Section D)
INVACARE CLEVELAND STREET
899 cleveland street
elyria OH 44036
Manufacturer (Section G)
INVACARE CLEVELAND STREET
899 cleveland street
elyria OH 44036
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5359646
MDR Text Key35976240
Report Number1219590-2016-00004
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Replace
Type of Report Initial
Report Date 12/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIH3800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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