MAUDE Adverse Event Report: BTE TECHNOLOGIES PRIMUS; REHABILITATION AND EVALUATION EQUIPMENT

Model Number PRIMUSRS

Device Problem Use of Device Problem (1670)

Patient Problem Limb Fracture (4518)

Event Date 11/16/2021

Event Type  Injury  

Event Description

Customer complained that primus exercise tool moved beyond the range of motion set by the operator, resulting in a wrist fracture of the patient.The evidence shows that the primus did not malfunction and did exactly what was commanded by the operator.The data contradicts the customer claim that the device continued to operate beyond the range of motion.

Manufacturer Narrative

The device communication logs provided by the customer were analyzed at bte.The evidence shows that the primus did not malfunction and did exactly what was commanded by the operator.The data contradicts the customer claim that the device continued to operate beyond the range of motion.Based on the most likely scenario developed using the obtained data, unintentional misuse is the root cause of the incident: the patient was not in the proper position while exercising on the device.The primus is intended to be used by medical healthcare professionals that are responsible for proper client positioning.

• Brand Name: PRIMUS
• Type of Device: REHABILITATION AND EVALUATION EQUIPMENT
• Manufacturer (Section D): BTE TECHNOLOGIES; 7455-l new ridge road; hanover MD 21076
• Manufacturer (Section G): BTE TECHNOLOGIES; 7455-l new ridge road; hanover MD 21076
• Manufacturer Contact: ewa kaczanowska ; 7455-l new ridge road; hanover, MD 21076 ; 4108500333
• MDR Report Key: 13078517
• MDR Text Key: 282725466
• Report Number: 1119903-2021-00002
• Device Sequence Number: 1
• Product Code: ISD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K933611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRIMUSRS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other