Device product
TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT¿ 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Z-0949-2013
Product summary
- Firm
- Hill-Rom, Inc.
- Event
- Event 64580
- Status
- Terminated
- Classification
- Class II
- Quantity
- 309
- Official record key
device-enforcement:Z-0949-2013
Official wording
Reason: In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested,
Code information: S/N between N230AM1358 & O023AM3687.
Distribution pattern: USA Nationwide Distribution including the state of Canada
Derived failure modes
-
Device software or design
software problem