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

Model Number IH3652G

Device Problems No Device Output (1435); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Per provider no air coming out unit turns on but runs very quiet.

• 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: patricia medina ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3630538
• MDR Text Key: 4203434
• Report Number: 1219590-2014-00037
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/28/2014

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: Other
• Device Model Number: IH3652G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 02/17/2014
• 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