MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-02-16 for I-PORTAL NEURO-OTOLOGICAL TEST CENTER RCS-365 NA manufactured by Neuro-kinetics Inc..
[2439533]
The event occurred in the i-portal neuro-otological test center located at (b)(6). It appears that the system operator failed to properly secure the patent before testing, causing the pt to come out of the chair at a high speed of rotation. Neuro-kinetics has limited info of the event from the user. More investigation to follow.
Patient Sequence No: 1, Text Type: D, B5
[9712461]
Neuro-kinetics received no formal report from (b)(6) of the event. Neuro-kinetics became aware of the event from a phone call from (b)(6) (a clinician) that their device may need serviced after an injury had occurred. The call was (b)(6) just prior to my (b)(6) scheduled annual preventive maintenance and safety inspection. He informed me that the pt did not have the foot or knee restraint in place to prevent his legs from being pulled outward by the centrifugal force. Neuro-kinetics did not receive any info on the seriousness of the injury and thus cannot be sure whether the threshold of "serious injury" has been met, but we are filing the report in an abundance of caution and are continuing to investigate. The findings of the device inspection were: the seat belts and shoulder belts show slight wear on the edges at the adjustment points but were sound and secure. The belt adjustment hardware adjusted freely and locked tight when pulled on. Buckles and anchor points were inspected, showed no signs wear or fatigue and functioned as designed. The foot restraints were found in a good functional condition and functioned as designed; all fasteners were found to be tight and the ratcheting mechanism functioned properly. The operator's station was set up efficiently with the e-stop button accessible while the pt viewing monitor is in operator's sight. It is important to note that the e-stop is the ultimate safety measure, designed for situations exactly like this to execute an immediate stop. Technician ran a full and thorough set of tests inspecting all plc functions, limits, and interlocks. All were inspected and found in proper working condition. The system functioned as designed. Further investigation pending info from user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2519945-2011-00001 |
| MDR Report Key | 2460621 |
| Report Source | 05 |
| Date Received | 2012-02-16 |
| Date of Report | 2011-10-21 |
| Date of Event | 2011-10-21 |
| Date Mfgr Received | 2011-10-21 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2012-02-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HOWISON SCHROEDER, CEO |
| Manufacturer Street | 128 GAMMA DRIVE |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal | 15238 |
| Manufacturer Phone | 4129636649 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-PORTAL NEURO-OTOLOGICAL TEST CENTER |
| Generic Name | NOTC ROTATIONAL CHAIR |
| Product Code | GWN |
| Date Received | 2012-02-16 |
| Model Number | RCS-365 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURO-KINETICS INC. |
| Manufacturer Address | PITTSBURGH PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-02-16 |