CLEARPOINT CP-HFF-212-01

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number7045130
MDR Report Key7045130
Date Received2017-11-20
Date of Report2017-11-03
Report Date2017-11-03
Date Reported to FDA2017-11-03
Date Reported to Mfgr2017-11-03
Date Added to Maude2017-11-20
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameCLEARPOINT
Generic NameTABLE, OPERATING-ROOM, AC-POWERED
Product CodeORR
Date Received2017-11-20
Model NumberCP-HFF-212-01
Catalog NumberCP-HFF-212-01
Device AvailabilityY
Device Age5 YR
Device Eval'ed by MfgrR
Device Sequence No0
Device Event Key0
ManufacturerMRI INTERVENTIONS, INC.
Manufacturer Address5 MUSICK IRVINE CA 92618 US 92618

Device Sequence Number: 1

Brand NameIMRIS T2X OR TABLE V2 (ORT100)
Generic NameTABLE, OPERATING-ROOM, AC-POWERED
Product CodeFQO
Date Received2017-11-20
Model NumberORT100
Catalog NumberCP-HFF-212-01
Device AvailabilityY
Device Age5 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerIMRIS - DEERFIELD IMAGING, INC.
Manufacturer Address5101 SHADY OAK RD MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-20

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