MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for PRIMUSRS manufactured by Bte Technologies, Inc..
[112746100]
Bte performed an analysis reviewing the shaft failure conditions. Inspection of cross-sections of the load cell shafts uncovered that the shaft will not be able to withstand the rated loads only when a unique and rare set of manufacturing conditions are encountered. The possibility of these conditions occurring only exists on a small subset of shafts. The probability that a shaft will fracture or separate is remote.
Patient Sequence No: 1, Text Type: N, H10
[112746101]
Primus load cell shaft fractured and separated while patient was exercising on the primus. No injury occured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119903-2018-00002 |
| MDR Report Key | 7642962 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-28 |
| Date Mfgr Received | 2018-05-29 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2018-06-27 |
| 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 |
| 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 | 0 |
| Brand Name | PRIMUSRS |
| Generic Name | PRIMUS |
| Product Code | ISD |
| Date Received | 2018-06-27 |
| Model Number | PRIMUSRS |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-06-27 |