Description of Event or Problem · 1
ACTUAL DATE OF THIS EVENT IS UNKNOWN, BUT IT OCCURRED DURING THE 7/1/93 - 12/31/93 REPORTING PERIOD. THE EVENT WAS NOT REPORTED TO BIOMEDICAL ENGINEERING UNTIL 1/25/94 AND THEN NOT FOR INVESTIGATION PURPOSES, ONLY FOR COMMENT/INFORMATION AFTER A MORE RECENT (1/21/94) INCIDENT. WHAT WAS REPORTED WAS THAT AN ANGIOGRAM WAS BEING PERFORMED WHERE THE PT HAD TO BE POSITIONED IN SUCH A WAY, BECAUSE THE TABLE HAD NO TRANSVERSE MOVEMENT, THAT HE HAD FALLEN OFF THE TABLE AND BROKEN HIS PELVIS. FOLLOWING THE 1/21/94 INCIDENT WHEN ANOTHER PT FELL OF THIS TABLE, THE SAFETY MGR WAS CALLED ON 1/27/94 TO OBSERVE A PROCEDURE BECAUSE RADIOLOGY SVC WANTED A STATEMENT FROM HIM THAT THE CURRENT TABLE WAS UNSAFE SINCE (1) TRANSVERSE TRAVEL WASN'T AVAILABLE, (2) THE TABLE WAS SO NARROW, AND (3) POSITIONING OF THE PTS FOR THESE PROCEDURES WAS UNSAFE. RPTR CALLED THE MFR TO OBTAIN INFO ON 1/27/94; THAT SAME DATE AN INVESTIGATION BY BIOMEDICAL ENGINEERING FOLLOWED TO DETERMINE THE VALIDITY OF INFO PROVIDED BY THE MFR: (1) THAT 3 VELCRO STRAPS, WHICH COULD BE MOVED TO THE REQUIRED LOCATION, WERE PROVIDED TO SECURE THE PT TO THE TABLE AND (2) THAT THE TABLE HAD 67" LONGITUDINAL AND 10" TRANSVERSE TRAVEL. BOTH CONDITIONS, IN REGARDS TO INFO PROVIDED TO RPTR BY THE MFR, WERE TRUE. IT WAS DETERMINED DURING THE PROCEDURE OBSERVED BY THE SAFETY MGR THAT THE PT WAS NOT SECURED TO THE TABLE WITH THE VELCRO STRAPS PROVIDED WITH THE TABLE. IT IS HIGHLY SUSPECT THAT THE VELCRO STRAPS WERE NOT IN USE AT THE TIME OF THIS INCIDENT EITHER. RPTR HAS NO INFO AS TO THE PT'S TEST/LAB DATA, OTHER RELEVANT HISTORY OR PRE-EXISTING CONDITIONS, CONCOMITANT MEDICAL PRODUCTS, THERAPY DATES, ETC. DUE TO LACK OF EARLY NOTIFICATION AND NO IN-HOUSE INVESTIGATION WAS CONDUCTED BY SAFETY MGMT AND BIOMEDICAL ENGINEERING AT THE TIME OF THE INCIDENT. (*)