FDA 483 - Invacare Corporation - August 18, 2010

This FDA Form 483 details multiple observations regarding Invacare's medical bed systems, citing deficiencies in corrective and preventive actions (CAPA), risk analysis, design validation, personnel training, and Medical Device Reporting (MDR).

**Key Violations and Observations:**

* **Observation 1 (CAPA Deficiencies):** * Failure to adequately document CAPA activities and results. * Inadequate corrective action for entrapment reports, including deaths, involving Invacare models # 5490NC, 5770NC, 5890NC, 5491NC, 5891NC, 5890PMI, 5490PMI, 5000NC, 5000PMI, 6000PMI, 6010PMI, VC5000, C5890 beds, and bed rails # 6628, 6629. Design changes implemented in 2007 were not applied to field units, except for a mattress recall. * Failure to take preventive action for ICCI bed systems (Echo, Arm, Arro beds with various rails) despite internal risk assessments indicating increased entrapment risk. * Inadequate complaint investigations for multiple entrapment incidents (Complaints #2010, #22