Device product
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
Z-1247-2015
Product summary
- Event
- Event 68235
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,034 units
- Official record key
device-enforcement:Z-1247-2015
Official wording
Reason: The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Code information: All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.