MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-03 for LEGEND PNEUMATIC MOTOR PM100-R manufactured by Mdt Powered Surgical Solutions.
[178145266]
No conclusion can be drawn. No evaluation was performed, as the device was not returned. If the device is returned in the future, product analysis may be performed. The device user manual warnings section includes instructions to check the device for damage before use. If damage is found, the device should not be used. The preventive maintenance/service manual for the legend system specifies service intervals for devices based on the hospital usage level. The maximum specified service interval is 24 months. Device has been in use for approximately 81 months with no record of factory service during this period. We will continue to track and trend this complaint type. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178145267]
Repair request initiated for device with the report of not working and has poor air flow. It was reported that there was no patient or staff impact but there was prolonged exposure to anesthesia and procedure delay to get another drill. Repair request escalated to product event due to customer indication that this report is a complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625507-2020-00017 |
| MDR Report Key | 9661569 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-03 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-02-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 4620 NORTH BEACH STREET |
| Manufacturer City | FT. WORTH TX 761373291 |
| Manufacturer Country | US |
| Manufacturer Postal | 761373291 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Street | 4620 N BEACH ST |
| Manufacturer City | FORT WORTH TX 76137 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76137 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGEND PNEUMATIC MOTOR |
| Generic Name | MOTOR, DRILL, PNEUMATIC |
| Product Code | HBB |
| Date Received | 2020-02-03 |
| Model Number | PM100-R |
| Catalog Number | PM100-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Address | 4620 N BEACH ST FORT WORTH TX 76137 US 76137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-03 |