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ECHO TABLE

Received May 16, 2011 · Event occurred Feb 25, 2011

Report 1932056-2011-00005 · MDR key 2108205

Device

Generic name

Echocardiography Procedure Table

Model number

1283

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