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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES

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MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES Back to Search Results
Catalog Number 6875
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2016
Event Type  malfunction  
Manufacturer Narrative
The following elements have blank data: unique device identifier (udi): for type of device: table, surgical with orthopedic accessories.
 
Event Description
After intubation for surgery, the patient's right leg began to slip from hana table. Anesthesiologist and or staff present found it necessary to carefully lower patient to the floor. According to staff interviewed, the patient was heavy set (b)(6) with weight mostly in the mid-section. Boots in hana bed was still not in place. Needed more than two staff to secure patient in hana bed.
 
Event Description
After intubation for surgery, the patient's right leg began to slip from hana table. Anesthesiologist and or staff present found it necessary to carefully lower patient to the floor. According to staff interviewed, the patient was heavy set ((b)(6) kgs) with weight mostly in the mid-section. Boots in hana bed was still not in place. Needed more than two staff to secure patient in hana bed.
 
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Brand NameHANA TABLE
Type of DeviceTABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
30031 ahern ave.
union city CA 94587
MDR Report Key6303585
MDR Text Key250892821
Report Number6303585
Device Sequence Number1
Product Code JEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2016,01/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6875
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2016
Event Location Hospital
Date Report to Manufacturer12/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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