MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT OASIS; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number OASIS

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Issue (2379); Human Factors Issue (2948)

Patient Problems No Patient Involvement (2645); Patient Problem/Medical Problem (2688)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

The oasis is a 1.2 tesla vertical field (open) mri system.The patient table has a movable top that is motorized and is used to position the patient within the magnet.Below the tabletop, there is a aluminum band in a recessed track that covers a chain drive.The band is only visible when the tabletop is extended into scanning position.The patient would never be in contact with this surface as the band is fully covered when the tabletop is retracted to the position where the patient is loaded/unloaded.When extended, the technologist brushed his finger across the band an caught it sufficiently to raise it out of the recessed area and allow the edge to cut his finger.This is the first report of this kind for the oasis product.

Event Description

The technologist was setting up a patient exam on the hitachi oasis mri system on (b)(6) 2017.During patient setup, the technologist went around the table end to speak with the patient.The table was set up for a lumbar study, and his finger was cut by the metal tape that runs down the center of the table.The table wasn't in motion, he just touched the metal tape without realizing tape is sharp.Initially he didn't feel anything, until he noticed the blood.The technologist confirmed on 6/12/2017 that he went to urgent care and got 4 stitches and was prescribed an antibiotic.

• Brand Name: OASIS
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer (Section G): HITACHI LTD. HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: douglas thistlethwaite ; 1959 summit commerce park; twinsburg, OH 44087 ; 3304251313
• MDR Report Key: 6641531
• MDR Text Key: 77580455
• Report Number: 8030405-2017-00002
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04580292768186
• UDI-Public: (01)04580292768186(11)160823(250)G210059416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Radiologic Technologist
• Device Model Number: OASIS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 91