MAUDE Adverse Event Report: BIODEX MEDICAL SYSTEMS BIODEX PRESTEP/BIOSTEP; ERGOMETER

Model Number 950-246

Device Problem Malposition of Device (2616)

Patient Problem Limb Fracture (4518)

Event Date 06/01/2019

Event Type  Injury  

Event Description

When starting exercise with the armrest of the new seat back to the original position, patient broke the wrist.

• Brand Name: BIODEX PRESTEP/BIOSTEP
• Type of Device: ERGOMETER
• Manufacturer (Section D): BIODEX MEDICAL SYSTEMS; 49 natcon dr; shirley NY 11967
• Manufacturer Contact: amaris ajamil
• MDR Report Key: 18196542
• MDR Text Key: 328883778
• Report Number: 2431314-2019-95256
• Device Sequence Number: 1
• Product Code: ISD
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 950-246
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention