Device product
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
Z-1864-2012
Product summary
- Firm
- Hill-Rom, Inc.
- Event
- Event 62331
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7843 devices
- Official record key
device-enforcement:Z-1864-2012
Official wording
Reason: During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.
Code information: AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
Derived failure modes
-
Unknown
During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.