Description of Event or Problem · 1
THE CUSTOMER CONTACTED VERATHON INC. INDICATING THAT A GLIDESCOPE VIDEO BATON 1-2 AND THE PGVL MONITOR WAS USE TO ATTEMPT INTUBATION DURING A CARDIAC ARREST IN A CHILD AT THE (B)(6) HOSPITAL ON (B)(6) 2013. THE PT DIED. THE MONITOR FAILED TO DELIVER A SATISFACTORY IMAGE WHEN TURNED ON. THE (B)(6), SAID THAT THE FAILED GLIDESCOPE IMAGE WAS NOT CAUSAL OF THE ADVERSE PT OUTCOME AND ITS NORMAL USE WOULD NOT HAVE CHANGED THE OUTCOME. THE USER SETTINGS FOR THE MONITOR WERE SET AT LOW BRIGHTNESS, RESULTING IN A DARK IMAGE TO BE DISPLAYED. (B)(6) INDICATED THAT AT SOME TIME PRIOR TO THE INCIDENT, THE SETTINGS FOR THE DEVICE WERE SET TO A VERY LOW LEVEL. THESE SETTINGS WERE SELECTED AND SAVED BY THE PREVIOUS USER OF THE DEVICE AT THE FACILITY. THE DEVICE WAS TESTED BY BOTH THE CUSTOMER'S INVESTIGATION TEAM (B)(6) AND VERATHON MEDICAL (B)(4). BOTH INVESTIGATIONS DID NOT IDENTIFY A DEVICE MALFUNCTION.