MAUDE Adverse Event Report: UNKNOWN IVC I-FIT SHWER CHAIR W/O BACK 2/CARTON 9153641764; ADAPTOR, HYGIENE

Model Number 9780

Device Problems Misassembled (1398); Use of Device Problem (1670)

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

Event Type  malfunction  

Event Description

(b)(6) 2015 - the dealer states that the device was assembled in the home, and when the end user went to use it, the front left leg supposedly dropped down 2 inches on the end user.The dealer is not sure if it was assembled properly because they did not inspect.The dealer is not sure if the device was actually used and dropped under weight or if the device dropped when it was placed in the shower.The dealer exchanged the device out for the end user.The dealer has no further information to provide.

Manufacturer Narrative

Additional information will be added as it becomes available.

• Brand Name: IVC I-FIT SHWER CHAIR W/O BACK 2/CARTON 9153641764
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; 1200 taylor street; elyria, OH 44036
• MDR Report Key: 4818857
• MDR Text Key: 20145253
• Report Number: 1525712-2015-03263
• Device Sequence Number: 1
• Product Code: IKX
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2015
• 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 Outcome(s): Other