Device product
OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056
Z-2597-2021
Product summary
- Firm
- Hill-Rom, Inc.
- Event
- Event 88548
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 440 units
- Official record key
device-enforcement:Z-2597-2021
Official wording
Reason: Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
Code information: N/A
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DE, IL, ME, MI, MO, MS, NJ, OH, PA, VA, WA and the countries of Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates.
Derived failure modes
-
Unknown
Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.