MAUDE Adverse Event Report: INVACARE CLEVELAND STREET IMMERSION HYDROBATH; 890.5100

Model Number IH1900IH3652GW

Device Problem Thermal Decomposition of Device (1071)

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

Event Type  malfunction  

Event Description

Per provider, customer is complaining of burning smell.

• Brand Name: IMMERSION HYDROBATH
• Type of Device: 890.5100
• 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: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3959679
• MDR Text Key: 18039352
• Report Number: 1219590-2014-00109
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH1900IH3652GW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/28/2014
• 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