SKYTRON
Received Jul 25, 2012
Report 1825014-2012-00007 · MDR key 2680697
Product problems
- Break
Patient
*
- Contusion
Narrative
Description of Event or Problem
IN RESPONSE TO (B)(6) MDR# (B)(4). DEVICE MANUFACTURE DATE: 11/2011. SKYTRON RECEIVED THE 3501C SURGICAL TABLE BACK FROM THE (B)(6) ON (B)(4) 2012. A COMPREHENSIVE ASSESSMENT AND EVAL WILL BE CONDUCTED AND DOCUMENTED. SKYTRON IS COORDINATING SENDING 2 REPS TO (B)(6) FOR FURTHER INTERVIEWS AND INVESTIGATIONS. ADDITIONALLY, WE ARE RETURNING THE TABLE TO THE MFR IN (B)(4) FOR THEIR THOROUGH INVESTIGATION AND REVIEW. WHEN WE RECEIVE THEIR REPORT, SKYTRON WILL RESUBMIT A FINAL MDR.