MAUDE Adverse Event Report: INVACARE CLEVELAND STREET SITZ BATH 1616700692; BATH, SITZ, NONPOWERED

Model Number IH3652G

Device Problem Device Maintenance Issue (1379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This tub is in need of a door seal which is covered under the lifetime warranty of the tub.No further details provided.

Manufacturer Narrative

Follow up to be sent if additional information is received.

• 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 Key: 4843757
• MDR Text Key: 5913351
• Report Number: 1219590-2015-00094
• Device Sequence Number: 1
• Product Code: KTC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IH3652G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 06/15/2015
• 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 Number: 1
• Patient Outcome(s): Other