OBM DAB (DIGITAL ACQUISITION BOX)

Description of Event or Problem

OBM DAB HAS LABEL INSTALLED UPSIDE DOWN. NEONATAL TRIGGER TOOL: HYPOTHERMIA INITIATED AT 2245. PATIENT WAS A CODE PINK IN FBU, BORN AT 1938. APGARS 0,0, 0 AT 1,5 AND 10 MINS. CHEST COMPRESSIONS AND EPINEPHRINE GIVEN DURING RESUSCITATION. COOLING STARTED AT 2220 USING CRITICOOL MACHINE AND BRAINZ MONITORING STARTED AT 2245. IT WASA REALIZED THAT THE NATUS AFFECTED MODULE (DEVICE H20080435, MODULE OBM00002G2379 ) FOR THE BRAIN MONITOR HAS THE LABEL STICKER ON BACKWARDS WHICH IS THE ROOT CAUSE FOR THE REPORTED ISSUE OF THE ISSUE WITH THE BRAINZ MONITOR IS THAT THE ELECTRODES ON THE HEAD MATCHES THE PICTURE ON THE MODULE. HOWEVER WHEN ITS CONNECTED TO THE BRAINZ MONITOR IT'S OPPOSITE."

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT # (B)(4). MAY 20, 2025 THE DEVICE WAS RECEIVED FOR EVALUATION: UPON INVESTIGATION IT WAS FOUND THAT THE LABEL WHICH DENOTES THE CONNECTIONS OF THE ELECTRODES AND THE ELECTRODE ORIENTATION WAS INSTALLED UPSIDE-DOWN. THE DATE OF MANUFACTURER OF THIS DAB WAS 2020-05-11. SUPPLIER CORRECTIVE ACTION SCAR-000067 WAS ISSUED TO NATUS CONTRACT MANUFACTURER. THE ROOT CAUSE WAS THE OPERATOR PLACED THE LABEL INCORRECTLY ON THE DEVICE AND DID NOT CHECK THE ASSEMBLY DRAWING. FOR CORRECTIVE ACTION, THE CONTRACT MANUFACTURER ADDED AN INSPECTION STEP TO THEIR VISION ROUTING FOR OBM00002 FOR THE ASSEMBLY PROCESS AND THE SYSTEM BUILD VERIFICATION STEP. A QUALITY NOTICE WAS CREATED, AND OPERATORS WERE TRAINED. THE FAILURE WAS CONFIRMED. INVESTIGATION RESULT CODE: NEURO SBU/LABELING ISSUE.

Description of Event or Problem

OBM DAB HAS LABEL INSTALLED UPSIDE DOWN. NEONATAL TRIGGER TOOL: HYPOTHERMIA INITIATED AT 2245. PATIENT WAS A CODE PINK IN FBU, BORN AT 1938. APGARS 0,0, 0 AT 1,5 AND 10 MINS. CHEST COMPRESSIONS AND EPINEPHRINE GIVEN DURING RESUSCITATION. COOLING STARTED AT 2220 USING CRITICOOL MACHINE AND BRAINZ MONITORING STARTED AT 2245. IT WAS A REALIZED THAT THE NATUS AFFECTED MODULE (DEVICE H20080435, MODULE OBM00002G2379 FOR THE BRAIN MONITOR HAS THE LABEL STICKER ON BACKWARDS WHICH IS THE ROOT CAUSE FOR THE REPORTED ISSUE OF THE ISSUE WITH THE BRAINZ MONITOR IS THAT THE ELECTRODES ON THE HEAD MATCHES THE PICTURE ON THE MODULE. HOWEVER, WHEN ITS CONNECTED TO THE BRAINZ MONITOR IT'S OPPOSITE."

Additional Manufacturer Narrative

INITIAL REPORT REF TO NATUS COMPLAINT#: (B)(4). CUSTOMER REPORTED OBM DAB HAS LABEL INSTALLED UPSIDE DOWN. PICTURES WERE PROVIDED AND THE ISSUE WAS CONFIRMED. THE CUSTOMER WAS REQUESTED TO RETURN THE AFFECTED DEVICE. TECHNICAL SERVICE ARRANGED FOR A REPLACEMENT. PER OBM RISK ANALYSIS SPREADSHEET (B)(4) REV 13. HAZARD ID 5.39 DEVICE LABEL DEPICTING ELECTRODE CONNECTION IS ATTACHED IN THE WRONG ORIENTATION. USER MISINTERPRETS DEVICE LABEL AND CONNECTS ELECTRODES SO THAT THE LEFT AND RIGHT CHANNELS ARE SWAPED. EFFECTS (HARM) - WRONG DIAGNOSIS - DISEASE PROGRESSION. FURTHER INVESTIGATION TO BE CARRIED OUT.