MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-04 for EVALTECH manufactured by Bte Technologies, Inc..
[41820836]
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.
Patient Sequence No: 1, Text Type: N, H10
[41820837]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119903-2016-00001 |
| MDR Report Key | 5545790 |
| Date Received | 2016-04-04 |
| Date of Report | 2016-03-04 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-03-04 |
| Device Manufacturer Date | 2015-11-06 |
| Date Added to Maude | 2016-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EWA KACZANOWSKA |
| Manufacturer Street | 7455-L NEW RIDGE ROAD |
| Manufacturer City | HANOVER MD 21076 |
| Manufacturer Country | US |
| Manufacturer Postal | 21076 |
| Manufacturer Phone | 4108500333 |
| Manufacturer G1 | BTE TECHNOLOGIES, INC. |
| Manufacturer Street | 7455-L NEW RIDGE ROAD |
| Manufacturer City | HANOVER MD 21076 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21076 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EVALTECH |
| Generic Name | EVALUATION SYSTEM USED TO ASSESS PHYSICAL CAPACITY OF SPECIFIC HUMAN FUNCTIONS |
| Product Code | IKK |
| Date Received | 2016-04-04 |
| Model Number | EVALTECH |
| Operator | PHYSICAL THERAPIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BTE TECHNOLOGIES, INC. |
| Manufacturer Address | 7455-L NEW RIDGE ROAD HANOVER MD 21076 US 21076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-04 |