MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-20 for CLEARPOINT CP-HFF-212-01 manufactured by Mri Interventions, Inc..
[92508187]
Patient Sequence No: 1, Text Type: N, H10
[92508188]
Imris or mri bed spontaneously moved 10 degrees from leveled plane at 90 degrees. Manufacturer response for holder, head, neurosurgical (skull clamp), clearpoint (per site reporter): customer service engineer was notified and rep evaluated bed and discovered issue with hydraulic manifold. Parts have been ordered, bed and or suite remain out of service.
Patient Sequence No: 1, Text Type: D, B5
[92938190]
Patient Sequence No: 1, Text Type: N, H10
[92938191]
Imris or mri bed spontaneously moved 10 degrees from leveled plane at 90 degrees. Manufacturer response for holder, head, neurosurgical (skull clamp), clearpoint (per site reporter): customer service engineer was notified and rep evaluated bed and discovered issue with hydraulic manifold. Parts have been ordered, bed and or suite remain out of service.
Patient Sequence No: 1, Text Type: D, B5
[92938286]
Patient Sequence No: 1, Text Type: N, H10
[92938287]
Imris or mri bed spontaneously moved 10 degrees from leveled plane at 90 degrees. Manufacturer response for holder, head, neurosurgical (skull clamp), clearpoint (per site reporter): customer service engineer was notified and rep evaluated bed and discovered issue with hydraulic manifold. Parts have been ordered, bed and or suite remain out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7045130 |
| MDR Report Key | 7045130 |
| Date Received | 2017-11-20 |
| Date of Report | 2017-11-03 |
| Report Date | 2017-11-03 |
| Date Reported to FDA | 2017-11-03 |
| Date Reported to Mfgr | 2017-11-03 |
| Date Added to Maude | 2017-11-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARPOINT |
| Generic Name | TABLE, OPERATING-ROOM, AC-POWERED |
| Product Code | ORR |
| Date Received | 2017-11-20 |
| Model Number | CP-HFF-212-01 |
| Catalog Number | CP-HFF-212-01 |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MRI INTERVENTIONS, INC. |
| Manufacturer Address | 5 MUSICK IRVINE CA 92618 US 92618 |
| Brand Name | IMRIS T2X OR TABLE V2 (ORT100) |
| Generic Name | TABLE, OPERATING-ROOM, AC-POWERED |
| Product Code | FQO |
| Date Received | 2017-11-20 |
| Model Number | ORT100 |
| Catalog Number | CP-HFF-212-01 |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMRIS - DEERFIELD IMAGING, INC. |
| Manufacturer Address | 5101 SHADY OAK RD MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-20 |