MalfunctionIKZ
ISOLIBRIUM PE SUPPORT SURFACE
Received Nov 21, 2025 · Event occurred May 16, 2025
Report 0001831750-2025-00747 · MDR key 23620818
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Product code (IKZ)
Model (297300000000)
Device
Generic name
Bed, Patient Rotation, Powered
Manufacturer
Stryker Medical-kalamazooCatalog number
297300000000
Product problems
- Positioning Problem
- Material Too Soft/Flexible
- Positioning Problem
- Material Too Soft/Flexible
Patient
NA · Unknown
- Pressure Sore/Ulcer
- Pressure Sore/Ulcer
Narrative
Additional Manufacturer Narrative
FURTHER INVESTIGATION IDENTIFIED THAT THE REPORTED ISSUES WERE DUE TO PUMP HOSES COMING DETACHED FROM THE MATTRESS AS WELL AS THE STAFF NOT SETTING THE PATIENT WEIGHT CORRECTLY. BASED ON AVAILABLE INFORMATION, STRYKER DETERMINED THAT THE PRESSURE INJURY WAS NOT SERIOUS IN NATURE.
Description of Event or Problem
NO NEW INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A PRESSURE INJURY DUE TO THE MATTRESS ADJUSTING THE PATIENT'S POSITIONING/WEIGHT DIFFERENTLY THAN THE CUSTOMER HAD SET IT TO.