ALGO5 CART BASE W TRANSFORMER 115V

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT#: (B)(4). RETURN OF THE AFFECTED PRODUCT WAS NOT POSSIBLE DUE TO THE CUSTOMER DISCARDING THE POWER INLET CABLE. THIS WAS A KNOWN ISSUE PREVIOUSLY INVESTIGATED. THE ISSUE WAS ADDRESSED BY ECO#: 39443 RELEASED 21-SEP-2022 WHICH INCLUDED THE FOLLOWING: PN#: 016026 ALGO 5 ASSEMBLY AND INSTALLATION INSTRUCTIONS, W/ ONYX-1721 PANEL PC UPDATED TO ADD A NOTE THAT ALL POWER CORDS ARE SECURED AND DOES NOT MAKE CONTACT WITH THE CASTER WHEELS. DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED - SYSTEM SHIPPED 14-AUG-2020 AND IS OVER 2 YEARS OLD. NO RELATED CAPAS. FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/CABLE DAMAGE.

Description of Event or Problem

ALGO5 CART BASE W TRANSFORMER 115V - A SPARK CAME FROM NEAR THE POWER INLET AND THE ALGO LOST POWER. NO INJURIES.

Description of Event or Problem

ALGO5 CART BASE W TRANSFORMER 115V - A SPARK CAME FROM NEAR THE POWER INLET AND THE ALGO LOST POWER. NO INJURIES.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). SHIP DATE WAS NOTED AS 14-AUG-2020 (FOR ALGO 5 DSP BOX ASSEMBLY). THE CUSTOMER REPORTED A SPARK FROM THE POWER INLET OF ALGO CART BASE. AFTER CALL BACK THE CUSTOMER PROVIDED ADDITIONAL INFORMATION THAT THE POWER CORD HAD BEEN DAMAGED DUE TO BEING DRAGGED ON THE FLOOR, INSULATION WORE THROUGH. REPLACEMENT POWER INLET AND ALGO5 CART BASE W TRANSFORMER 115V (PN (B)(6)) WERE SENT TO RESOLVE THE ISSUE. CUSTOMER ADVISED ON THE RELATED CASE THEY CAN RETURN THE TRANSFORMER BUT THE POWER INLET WAS DISCARDED SO IT CAN NOT BE RETURNED. RISK REVIEW: PER (B)(4) REV C ALGO 5 RISK ANALYSIS, HAZARD 2.1. CAUSE - AC MAINS SHORTED TO CART CHASSIS. AC MAINS FAULT - RESULTS IN AC MAINS VOLTAGE ON CART CHASSIS. EFFECT (HARM) - ELECTRICAL SHOCK - PATIENT OR USER RESIDUAL RISK - MODERATE. FURTHER INVESTIGATION TO BE CARRIED OUT.