MAUDE Adverse Event Report: BTE TECHNOLOGIES, INC. EVALTECH; EVALUATION SYSTEM USED TO ASSESS PHYSICAL CAPACITY OF SPECIFIC HUMAN FUNCTIONS

Model Number EVALTECH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2016

Event Type  Injury  

Manufacturer Narrative

Reported issue: during training practice on evaltech system, operator pulled on handles that had not been locked in the utm sides, lost balance, fell, and hit her head on the computer cart nearby.Reported injury: the operator was diagnosed with concussion and put on desk duty for few days.Pertinent information: the equipment is used in a hospital and the operator was evaluated by a doctor working at this location.The operator involved in the incident did not set up the equipment.The handles had been inserted into the utm by someone else.The operator was injured during a training session on the device.No patients were involved in the incident or present near the equipment.The equipment did not malfunction.Instructions how to secure attachments such as handles are provided in the device manual.There is no need to evaluate the device or similar devices.The users realized that they have made a mistake.Also, bte staff verified that the equipment functions properly during in-service performed on (b)(6) 2015.The operator who fell down brought up the issue to the bte instructor on (b)(6) 2016 during level 2 training class conducted at bte headquarters in (b)(4).The operator was interviewed at that time and the issue was directly discussed with the user.She did not complain of any long-term effects from the incident and seemed to be fine.Root cause: user error - the mechanism designed to lock attachments in the utm sides was not engaged that would have prevented this incident.Contributing factors: instructions were not followed/consulted prior to use.The operator did not verify the equipment settings prior to use.Risk assessment: the risk associated with this issue is acceptable based on the criteria of a low probability and moderate severity.The probability of occurrence of an incident related to handles not secured in the device is remote based on historical data.The probability of such incident occurrence is estimated as (b)(4).Moderate severity includes reversible or minor injury that could be the result of person falling down.Corrective action review: no corrective action will be issued at this time.The incident is not attributed to the device malfunction or inadequate bte processes.New users were training themselves on the equipment and realized that they made an error.No correction or withdrawal will be conducted.Users realized they have made a mistake.

Event Description

During training practice on evaltech system, operator pulled on handles that had not been locked in the utm sides, lost balance, fell, and hit her head on the computer cart nearby.The equipment is used in a hospital and the operator was evaluated by a doctor working at this location.The operator was diagnosed with concussion and put on desk duty for few days.

• Brand Name: EVALTECH
• Type of Device: EVALUATION SYSTEM USED TO ASSESS PHYSICAL CAPACITY OF SPECIFIC HUMAN FUNCTIONS
• Manufacturer (Section D): BTE TECHNOLOGIES, INC.; 7455-l new ridge road; hanover MD 21076
• Manufacturer (Section G): BTE TECHNOLOGIES, INC.; 7455-l new ridge road; hanover MD 21076
• Manufacturer Contact: ewa kaczanowska ; 7455-l new ridge road; hanover, MD 21076 ; 4108500333
• MDR Report Key: 5545790
• MDR Text Key: 41820836
• Report Number: 1119903-2016-00001
• Device Sequence Number: 1
• Product Code: IKK
• 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: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physical Therapist
• Device Model Number: EVALTECH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR