ECHO TABLE
Received May 16, 2011 · Event occurred Feb 25, 2011
Report 1932056-2011-00005 · MDR key 2108205
Device
Product problems
- Break
- Material Separation
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE TABLE WAS IN USE AND NEITHER A PT NOR USER-FACILITY STAFF MEMBER WERE INJURED DURING THE EVENT, MPI FEELS THAT A RECURRENCE OF THE EVENT WITH A PT ON THE PRODUCT COULD LEAD TO AN ADVERSE EVENT. A CRITICAL WELD ON THE PRODUCT WAS BROKEN WHEN WEIGHT WAS APPLIED TO THE TABLE BY THE PLACEMENT OF INANIMATE OBJECTS ON THE TABLE. THE WELD SEPARATION CAUSED THE HEAD END OF THE TABLE TO FALL TO THE FLOOR. IF THIS HAD OCCURRED WHILE IN USE WITH A PT, THE EVENT COULD HAVE LEAD TO CONTUSIONS AND BRUISING FROM SUCH A FALL.
Additional Manufacturer Narrative
UPON EVAL IT WAS NOTED THAT THE CAUSE OF THE PROBLEM WAS A "COLD WELD" WHICH DIDN'T PENETRATE PROPERLY AND WAS ABLE TO SEPARATE WHEN WEIGHT WAS APPLIED TO THE PRODUCT. MPI OPENED (B)(4) TO INVESTIGATE THE ISSUE TO DETERMINE THE ROOT CAUSE FOR THE PROBLEM, AND TO DETERMINE IF A FIELD CORRECTION IS NECESSARY FOR THE ISSUE.
Remedial action
- Replace