MAUDE Adverse Event Report: THE STANDING COMPANY SUPERSTAND; STAND UP WHEELCHAIR

Model Number HPS-2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

On (b)(6) 2014, the standing company was notified by the case manager of the quadriparesis client that the client had been hospitalized.According to the case manager, the client said he was attempting to do push-ups (i.E.Strengthen his upper body and/or to provide relief to his skin) while in his wheelchair.The case manager said the client said he had his tibia supports on/installed, but did not have the armrest properly placed in front of him nor did he have his seat belt fastened.The case manager stated the client said as his chair started moving upward that "he (the client) panicked".He inadvertently leaned forward and grabbed for "something".The client said he then fell forward.The client broke his right tibia plateau (right lower leg near knee).The client, according ot the case manager was transported to a local hospital on (b)(6) 2014 and had surgery on both legs to stabilize the fracture.The client will then be in rehab facility for a length of time.

Manufacturer Narrative

Based on what the case manager stated the client said, the standing company has attempted to duplicate client's problem but unable to do so.The standing company's service manager, a t-7 paraplegic who on a daily basis uses the exact same wheelchair the client uses, cannot - based on what the case manager stated the client said - recreate the incident.The case manager says she and the client - upon his return home - want tsc to (once again) provide the client with a refresher course regarding chair operation.We will comply.On (b)(4) 2014, a representative from the standing wheelchair company (tsc) visited with the wife of the client.During this time the representative of tsc inspected the chair.He drove chair and inspected the standing mechanism by going up and down in chair.He also assessed the armrest and the seatbelt for any issues.No issues were found.The evaluations deemed the chair to be fully functioning and in good working order.

• Brand Name: SUPERSTAND
• Type of Device: STAND UP WHEELCHAIR
• Manufacturer (Section D): THE STANDING COMPANY; saginaw MI
• Manufacturer Contact: 5848 dixie highway; saginaw, MI 48601-0000 ; 9897469100
• MDR Report Key: 3876255
• MDR Text Key: 4461985
• Report Number: 3007494904-2014-00001
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HPS-2
• Other Device ID Number: SJ0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 136