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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 Problem Device Slipped (1584)
Patient Problems Fall (1848); Extubate (2402); Unintended Extubation (4564)
Event Date 12/18/2019
Event Type  malfunction  
Event Description
It was reported following anesthesia induction the table tilted 90 degrees.The patient, the anesthesiologist, and the resident fell to the floor.The patient was extubated.Cat scans and x-rays revealed no new injuries to the patient.No injuries to staff were reported.
 
Manufacturer Narrative
The reported incident was improper maintenance on the table as it was not maintained as per the manufacturer's guidelines.It was reported within the document "(b)(4)," that a pin replacement was purchased but not through the manufacturer.The event occurred in (b)(6) 2019, the table was 11 years old, outside of product lifetime.
 
Event Description
It was reported following anesthesia induction the table tilted 90 degrees.The patient, the anesthesiologist, and the resident fell to the floor.The patient was extubated.Cat scans and x-rays revealed no new injuries to the patient.No injuries to staff were reported.
 
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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 94587 1234
MDR Report Key10159251
MDR Text Key195300431
Report Number2921578-2020-00020
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 distributor,foreign
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? Yes
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 Received05/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age41 YR
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