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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA; SURGICAL OPERATING TABLE

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MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA; SURGICAL OPERATING TABLE Back to Search Results
Model Number 6875
Device Problems Device Slipped (1584); Insufficient Information (3190); Device Handling Problem (3265)
Patient Problem Fall (1848)
Event Date 10/12/2019
Event Type  malfunction  
Event Description
It was reported that a patient fell off the operating table.
 
Manufacturer Narrative
Field service inspected the table to check if there were any contributing defects, and none were found.Staff members forgot to lock the casters, and they lost their grip on patient.Arrangements were made for a refresher in-service training with staff.No information was provided regarding any patient injury.
 
Event Description
It was reported that a patient fell off the operating table.
 
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Brand Name
HANA
Type of Device
SURGICAL OPERATING TABLE
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern avenue
union city CA 94587 1234
MDR Report Key9252126
MDR Text Key183888116
Report Number2921578-2019-00039
Device Sequence Number1
Product Code JEA
UDI-Device Identifier00842430108747
UDI-Public00842430108747
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 12/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number6875
Device Catalogue Number6875
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/14/2019
Initial Date FDA Received10/29/2019
Supplement Dates Manufacturer Received10/14/2019
Supplement Dates FDA Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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