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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 TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

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MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED Back to Search Results
Model Number 5803
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 04/03/2019
Event Type  malfunction  
Event Description
The bed disengaged while patient was still on the bed.
 
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Brand NameADVANCED CONTROL I-BASE, DC
Type of DeviceTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city CA 94587
MDR Report Key8586190
MDR Text Key144278195
Report Number8586190
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5803
Device Catalogue Number5803
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/08/2019
Device Age9 YR
Event Location Hospital
Date Report to Manufacturer05/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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