MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-06 for PRIMUSRS manufactured by Bte Technologies, Inc..
[104661593]
The unit communication logs match the scenario and timeline described by the customer and indicate that user error caused the incident. The therapist set very low resistance forces that were under 1 lb. However, the therapist was probably expecting a much higher resistance when using the system. He fell because there was no resistance on the cable due to his data entry error. The equipment is capable to provide up to 140 lbs. Resistance while tool 191 is utilized.
Patient Sequence No: 1, Text Type: N, H10
[104661594]
Physical/occupational therapist that operated the device was demonstrating a pull exercise. He intended to walk backwards while pulling tool 191 cable. He pulled on the cable and lost his balance due to no resistance. He fell and is awaiting authorization for physical therapy for lower back injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119903-2018-00001 |
| MDR Report Key | 7405254 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-06 |
| Date of Report | 2018-03-07 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-03-07 |
| Device Manufacturer Date | 2005-11-02 |
| Date Added to Maude | 2018-04-06 |
| 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 | OCCUPATIONAL 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMUSRS |
| Generic Name | PRIMUS |
| Product Code | ISD |
| Date Received | 2018-04-06 |
| Model Number | PRIMUSRS |
| 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 | 2018-04-06 |