MAUDE Adverse Event Report: INVACARE TAYLOR STREET SHOWER CHAIR PADDED VINYL 9153633401; ADAPTOR, HYGIENE

Model Number UNKNOWN

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

As described by the user she sat on the toilet chair when suddenly the product tilted sidewards.As investigated by the dealer the height adjustment pin did not work properly due to too many painting on the frame.Afer removing some paint, the height adjustment worked properly.The omega eco h440 commode has some features that are the same /similar to products which are manufactured and/or marketed by invacare in the u.S.The alleged incident occurred in (b)(6).

Event Description

As described by the user, she sat on the toilet chair when suddenly the product tilted sideways.As investigated by the dealer the height adjustment pin did not work properly due to too much paint on the frame.Afer removing some paint, the height adjustment worked properly.The omega eco h440 commode has some features that are the same /similar to products which are manufactured and/or marketed by invacare in the u.S.The alleged incident occurred in (b)(6).

• Brand Name: SHOWER CHAIR PADDED VINYL 9153633401
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5379203
• MDR Text Key: 36437997
• Report Number: 1525712-2016-00196
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/24/2015
• 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 Age: 68