Device product
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Z-2625-2026
Product summary
- Event
- Event 99035
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 962 units
- Official record key
device-enforcement:Z-2625-2026
Official wording
Reason: Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
Code information: GTIN: 07630002800839/ Lot # range: 00001 -19732
Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, ND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.
Derived failure modes
-
Unknown
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.