NEUROMONITOR, 220-240C
Received Sep 23, 1997 · Event occurred Aug 1, 1997
Report 1219655-1997-00141 · MDR key 122123
Device
Generic name
Spinal Fluid Pressure Monitor, Electrical
Manufacturer
Johnson And Johnson Professional, Inc.Model number
NACatalog number
82-6601
Lot number
NA
Patient
NO INFO
Narrative
Description of Event or Problem
THE ICP GRAPH/ICP VALUE DID NOT CORRESPOND TO THE PT'S ACTUAL CONDITION. THE PT'S CONDITION WORSENED, WHILE THE MONITOR SHOWED A VALUE WITHIN AN ACCEPTABLE RANGE. BECAUSE THIS COMPLAINT WAS REPORTED THROUGH CO'S FOREIGN FACILITY IN THAILAND, AND ENGLISH IS NOT THEIR FIRST LANGUAGE. THE CONDITION OF THE PT IS UNK AND THE ACTUAL EVENTS OF THE THE INCIDENT ARE NOT CLEAR. THE PT HAS DIED, BUT IS NOT KNOWN WHAT PRECIPITATED THE DEATH. MON/CONTROL UNIT CABLE, P/C 82-6622, MDR#1219655-1997-00142. CRANIAL DRILL BIT, 5.8MM, 82-6608, MDR#1219655-1997-00143. NEUROMONITOR BASIC KIT, P/C 82-6631, MDR#1219655-1997-00144.