MAUDE Adverse Event Report: RIFTON EQUIPMENT SMALL DYNAMIC STANDER; MOBILE STANDER

Model Number K130

Device Problem Material Separation (1562)

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

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

Visual analysis of the failed component suggests that there would likely have been visible cracking of the part well before the failure that resulted in this incident.Such cracking would be obvious to a user complying with the instructions in the device manual to periodically inspect the device for cracks.The product manual instructions say: "to prevent structural failure, which may result in serious injury or death: inspect this product and accessories regularly for loose or missing screws, metal fatigue, cracks, broken welds, missing attachments, general instability or other signs of excessive wear.Immediately remove this product from use when any condition develops that might make operation unsafe.".

Event Description

It was reported that as staff was putting the student into the mobile stander, a structural component of the stander failed, allowing the body support to separate from the frame of the stander.

• Brand Name: SMALL DYNAMIC STANDER
• Type of Device: MOBILE STANDER
• Manufacturer (Section D): RIFTON EQUIPMENT; 2032 rt 213; po box 903; rifton NY 12471
• Manufacturer Contact: travis scott ; 2032 rt 213; po box 903; rifton, NY 12471 ; 8456587722
• MDR Report Key: 5202090
• MDR Text Key: 30690083
• Report Number: 1319061-2015-00001
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physical Therapist
• Device Model Number: K130
• Device Catalogue Number: K130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1