HANA 6875 #6875

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-09 for HANA 6875 #6875 manufactured by Mizuhosi.

Event Text Entries

[20204476] The "fracture table" or arthroplasty table is shaped like an ironing board. The patient's head is at the wide end with the hips at the pointed end. A perineal post is inserted between the legs to prevent the patient from rolling. There is also an abdominal safety strap. The legs are placed in boots with traction applied, and are unsupported from below. This allows the legs to move on pivots to give greater surgical access and improve limb positioning. The patient was 80 kg. A sheet was placed beneath the patient at the beginning of the procedure to help with transfer back onto a stretcher for extubation at the end of the case. (the table is considered unsafe for intubation and extubation should emergency procedures arise. The perineal post was removed. The feet were removed from the boots and were being held by the surgeon. The anesthesiologist was holding the sheet at the head of the table. There was an rn on each side of the patient. An rn removed the abdominal strap, and turned momentarily to pull the stretcher (which was right beside her) up against the table. When the rn turned and took her hand away from the patient he began to slide to the floor. The weight of his hips was displaced to one side of the point in the table. Given that three people were still holding the patient and the 4th rn turned quickly, the patient had a controlled fall/slide to the floor. Manufacturer response (as per reporter) for hanahip and knee arthroplasty table, the manufacturer rep is coming to evaluate the product with us and attend a staff inservice.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1403485
MDR Report Key1403485
Date Received2009-06-09
Date of Report2009-06-09
Date of Event2009-05-29
Report Date2009-06-09
Date Reported to FDA2009-06-09
Date Added to Maude2009-06-18
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHANA
Generic NameHIP AND KNEE ARTHROPLASTY TABLE
Product CodeJFB
Date Received2009-06-09
Model Number6875
Catalog Number#6875
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age3 MO
Device Sequence No1
Device Event Key0
ManufacturerMIZUHOSI
Manufacturer Address30031 AHERN AVE. UNION CITY CA 94587 US 94587


Patients

Patient NumberTreatmentOutcomeDate
10 2009-06-09

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