TEC

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE BATTERY WAS REPLACED TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS MADISON - 3030 OHMEDA DR, USA MADISON, WI 53718.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL MDR IS BEING FILED TO CORRECT THE INITIAL MDR WHICH WAS REPORTED FOR THE INCORRECT MALFUNCTION. THIS SUPPLEMENTAL MDR IS BEING FILED TO REPORT THAT THE MALFUNCTION IS ASSOCIATED WITH RECALL NO. Z-0814-2025, GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT PER 21 CFR 806 ON 27-NOV-2024. THE FDA RECALL NUMBER IS (RECALL NO. Z-0814-2025). CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND INSTRUCTIONS FOR INSPECTING FOR CORRECT OUTPUT CONCENTRATION. GEHC WILL REPLACE ALL AFFECTED UNITS. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT.

Description of Event or Problem

AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 27-NOV-2024, (RECALL NO. Z-0814-2025) THIS UNIT WAS IDENTIFIED AS HAVING AN ISSUE WITH REDUCED CONCENTRATION DELIVERY OF ANESTHETIC AGENT. THERE WAS NO PATIENT INVOLVEMENT.