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

Model Number IH3652G

Device Problem Device Emits Odor (1425)

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

Event Type  malfunction  

Event Description

Facility reported that a jet motor for an (b)(4) side entry whirlpool tub was allegedly damaged when received, was causing a 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: 4009814
• MDR Text Key: 4779821
• Report Number: 1219590-2014-00120
• 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: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/07/2014

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: IH3652G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 08/14/2014
• 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