MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-19 for PRIMUS, BTE WS30 PRIMUSRS manufactured by Bte Technologies, Inc..
[15014789]
The operator was performing a continuous passive motion (cpm) test on a pt's wrist. The pt's hand was strapped to the sys attachment (tool) with velcro in accordance with the operating instructions. On one of the repetitions the primus travelled past the desired range of motion bending the pt's wrist upward. At this time a message was displayed indicating a communication issue with the primus. The pt was able to undo the straps and pull their arms out of the arm rest. The clinician then unplugged the machine. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[15330922]
As per normal bte svc process, replacement parts were provided to the clinic. However, parts from the customer site have not been returned yet to bte. It has been verified that the parts are in transit. The pt data will be available once parts from the customer site are rec'd at bte. The pt is an adult.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119903-2013-00002 |
| MDR Report Key | 3074880 |
| Report Source | 06 |
| Date Received | 2013-04-19 |
| Date of Report | 2013-04-19 |
| Date of Event | 2013-03-21 |
| Date Mfgr Received | 2013-03-21 |
| Device Manufacturer Date | 2006-09-29 |
| Date Added to Maude | 2013-06-24 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EWA KACZANOWSKA, REGULATORY M |
| Manufacturer Street | 7455-L NEW RIDGE RD. |
| 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 | PRIMUS, BTE WS30 |
| Product Code | ISD |
| Date Received | 2013-04-19 |
| Model Number | PRIMUSRS |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BTE TECHNOLOGIES, INC. |
| Manufacturer Address | HANOVER MD US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-19 |