MAUDE Adverse Event Report: DEERFIELD IMAGING, INC. IMRIS ORT100 OPERATING ROOM TABLE

Model Number ORT100

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

The ort100 table has not yet been evaluated.A follow-up report will be submitted once root cause has been established.

Event Description

The customer stated that the ort100 table stopped moving during daily testing.They observed hydraulic fluid in the control panel of the table.There was no patient involvement.

Manufacturer Narrative

The customer service engineer discovered that the hydraulic pump exhibited a hydraulic fluid leak.He repaired the pump, replaced the o-ring seal and dampening mounts, and replaced the hydraulic fluid.The table was functionally tested to verify proper function.

Event Description

The customer stated that the ort100 table stopped moving during daily testing.They observed hydraulic fluid in the control panel of the table.There was no patient involvement.

• Brand Name: IMRIS ORT100 OPERATING ROOM TABLE
• Type of Device: OPERATING ROOM TABLE
• Manufacturer (Section D): DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• MDR Report Key: 7854812
• MDR Text Key: 119499737
• Report Number: 3010326005-2018-00037
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORT100
• Device Catalogue Number: 110470-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 08/09/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1