Device product
Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use outside the 1,500 gauss (0.15 T) line during MR imaging for MRI systems up to 3.0 T. The device is intended for limited duration use, such as would be necessary during patient transports.
Z-0342-2020
Product summary
- Event
- Event 83857
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25,840 units
- Official record key
device-enforcement:Z-0342-2020
Official wording
Reason: Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Code information: All Lot manufactured from 08/31/14 to 08/07/2019
Distribution pattern: Worldwide distribution US Nationwide distributions in the states of OH, NY, PA, TX, MA, MI, KS, IL, MD, MN, WA, TN, UT, CA, NJ, LA, CT, OR, ND, RI, WI, PR, FL, ON, NV, NB, OK, IN, AZ, MS, GA, IA and countries of Costa Rica, Mexico.
Derived failure modes
-
Unknown
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range