FDA Adverse Event Injury Summary report: N

HANA TABLE

MDR report key: 4943367 · Received July 22, 2015

Report

Report Number
2921578-2015-00014
Event Type
Injury
Date Received
July 22, 2015
Report Date
April 28, 2016
Manufacturer
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Product Code
JEA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

NO FILES ATTACHED.

Additional Manufacturer Narrative · 1

IN-SERVICE TRAINING WAS PROVIDED FOR THE HOSPITAL PERSONNEL, WITH SPECIAL ATTENTION TO THE USE OF THE SAFETY STRAPS TO HELP PREVENT RECURRENCE OF THIS TYPE OF EVENT.

Description of Event or Problem · 1

PATIENT WAS POSITIONED SUPINE FOR HIP PINNING. LEFT LEG IN WELL LEG, BOTH ARMS CROSSED OVER CHEST, PERIPOST WAS ENGAGED. SAFETY STRAP WAS NOT (ON), INJURED LEG IN TRACTION BOOT. PATIENT PROCEEDED TO SLIDE OFF OF THE TABLE TO THE INJURED SIDE PRE-OP AFTER HAVING BEEN INTUBATED AND PARALYZED (SEDATED). ALTHOUGH PATIENT'S FOOT WAS IN THE BOOT, HIS HEAD DID HIT THE GROUND AND A HEAD AND NECK X-RAY WAS TAKEN TO SEE IF ANY INJURY OCCURRED. AT THIS TIME NONE SEEMS EVIDENT.

Description of Event or Problem · 1

PATIENT WAS POSITIONED SUPINE FOR HIP PINNING. LEFT LEG IN WELL LEG, BOTH ARMS CROSSED OVER CHEST, PERIPOST WAS ENGAGED. SAFETY STRAP WAS NOT (ON), INJURED LEG IN TRACTION BOOT. PATIENT PROCEEDED TO SLIDE OFF OF TABLE TO THE INJURED SIDE PRE-OP AFTER HAVING BEEN INTUBATED AND PARALYZED (SEDATED). ALTHOUGH PATIENT'S FOOT WAS IN THE BOOT, HIS HEAD DID HIT THE GROUND AND A HEAD AND NECK XRAY WAS TAKEN TO SEE IF ANY INJURY OCCURRED. AT THIS TIME NONE SEEMS EVIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
474332 HANA TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, ACPOWERED JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 6875

Patients

Seq Age Sex Outcome Treatment
1 92 YR Other