MAUDE Adverse Event Report: UNKNOWN IVC I-FIT SHOWER CHAIR W/BACK 9153641763; ADAPTOR, HYGIENE

Model Number 9781

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by an end user the leg height adjustment is not working on a 9781 shower chair.The legs will not lock into the height requested.

• Brand Name: IVC I-FIT SHOWER CHAIR W/BACK 9153641763
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4365152
• MDR Text Key: 16448644
• Report Number: 1531186-2014-06794
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2014,11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2014
• Distributor Facility Aware Date: 11/12/2014
• Date Report to Manufacturer: 12/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other