MAUDE Adverse Event Report: UNKNOWN IMMERSION HYDROBATH; 890.5100

Model Number 1149230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the (b)(4) bath seal needs replacement.

• Brand Name: IMMERSION HYDROBATH
• Type of Device: 890.5100
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4177287
• MDR Text Key: 18290926
• Report Number: 1525712-2014-07014
• 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: 09/26/2014

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: 1149230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 10/16/2014
• 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