MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for TRANSITION GATE BRACKET MOUNT FOR REG. TRACK 363980 manufactured by Prism Medical.
[41174327]
The transition gate parts have been requested back to evaluate. An investigation will be completed and a final report submitted after completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
[41174328]
Motor fell out of track when health care worker pushed it away after use. No one was injured.
Patient Sequence No: 1, Text Type: D, B5
[45775208]
Root cause: primary: indications of poor bracket positioning, increased deflection of the system, and excess wear on the brackets suggest that the installation is the primary cause. These issues prevented the guide screw from completely engaging with the ramp. Secondary: as the pin did not slide easily through the plastic linear bearings, the pin did not drop down as designed. Remaining in the "up" position, it allowed the lift to roll out of the track. Correction: check the installation to ensure it is level and does not have large gaps between the track. The transgate components returned should be replaced. Corrective action: primary: the installation of the remaining systems installed at the facility should be checked to ensure they are level and do not have large gaps between the track. The installation crew and facility staff should be retrained to confirm clear understanding of proper install/use of the gantry system. Secondary: the plastic bearing for the transgate was upgraded in mid-2015 (ecr 802) and current production utilizes a different metal roller bearing instead. The replaced transgate components will have metal roller bearings installed which should allow the drop pin to move more freely.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007802293-2016-00053 |
| MDR Report Key | 5518223 |
| Date Received | 2016-03-22 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-02-26 |
| Date Mfgr Received | 2016-02-26 |
| Device Manufacturer Date | 2014-02-28 |
| Date Added to Maude | 2016-03-22 |
| 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 | STEVE KILBURN |
| Manufacturer Street | 10888 METRO COURT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal | 63043 |
| Manufacturer Phone | 3142198614 |
| Manufacturer G1 | PRISM MEDICAL |
| Manufacturer Street | 10888 METRO COURT |
| Manufacturer City | MARYLAND HEIGHTS MO 63043 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63043 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSITION GATE BRACKET MOUNT FOR REG. TRACK |
| Generic Name | TRANSITION GATE |
| Product Code | FMR |
| Date Received | 2016-03-22 |
| Model Number | 363980 |
| Device Availability | * |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISM MEDICAL |
| Manufacturer Address | 10888 METRO COURT MARYLAND HEIGHTS MO 63043 US 63043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-22 |