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

Model Number IH3802G

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/08/2014

Event Type  malfunction  

Event Description

Water leaking around the bottom side of the door seal.To re-adjust door probe to add more tension on the door to seal.Advised to keep door open to prevent the life of the door seal.The care givers may have been keeping the door locked when not in use.

• 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: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4211473
• MDR Text Key: 16852105
• Report Number: 1219590-2014-00176
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/08/2014

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: IH3802G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 10/29/2014
• 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