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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC; SURGICAL OPERATING TABLE
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MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC; SURGICAL OPERATING TABLE Back to Search Results
Model Number 5803
Device Problems Device Slipped (1584); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that the table attempted to be moved/tilted in the operating room (or) and the patient almost fell down - status of the patient unknown.
 
Manufacturer Narrative
The head-end and foot-end crossbars were not holding at 9 5ft/lbs.And needed to be adjusted to hold at 95ft/lbs.The owner's manual says, "a preventative maintenance (pm) check on this product is required at least once every year.Note: if the device is excessively or abusively used, the manual rotation locking mechanism and foot-end locking mechanism should be regularly checked to ensure the 95 ft/lb torque is maintained." the last recorded pm check was in 2018.
 
Event Description
It was reported that the table attempted to be moved/tilted in the or and the patient almost fell down - status of the patient unknown.
 
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Brand Name
ADVANCED CONTROL I-BASE, DC
Type of Device
SURGICAL OPERATING TABLE
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city, ca
MDR Report Key9763213
MDR Text Key183889738
Report Number2921578-2020-00010
Device Sequence Number1
Product Code JEA
UDI-Device Identifier00842430106026
UDI-Public00842430106026
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 05/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5803
Device Catalogue Number5803
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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