AXIOM MULTIX, MT, ACSS, N

Description of Event or Problem

THE TOUCH SCREEN MONITOR OF THE SYSTEM CANNOT BE TURNED ON. THE PLASTIC PLUG FROM THE POWER SUPPLY THAT IS PLUGGED INTO THE MONITOR IS PARTIALLY MELTED DUE TO HEAT. THE USER STATED THAT IT SMELLED HOT. THE COMPLAINT WAS NOT DEEMED REPORTABLE WHEN IT WAS FIRST RECEIVED BY SIEMENS HEALTHCARE ON 2022-09-26. ADDITIONAL INFORMATION WAS RECEIVED AND REVIEWED ON BY SIEMENS HEALTHCARE ON 2023-07-12 (NEW AWARENESS DATE). DURING INVESTIGATION OF ANOTHER COMPLAINT FOR THE SAME SYSTEM TYPE ((B)(4)), REPORTED TO THE FDA ON 2022-11-02 (MFR. REPORT # 3004977335-2022-50607) WHERE THE SYSTEM MONITOR CAUGHT FIRE, IT WAS DETERMINED THAT THE CAUSE OF THE OVERHEATED POWER SUPPLY PLUG OF THIS CASE MIGHT HAVE BEEN RELATED TO THE OTHER COMPLAINT. IT WAS DETERMINED THAT IN BOTH CASES A SHORT CIRCUIT IN THE PLUG MIGHT HAVE LED TO OVERHEATING OF THE PLUG. EVEN THOUGH THIS CANNOT BE PROVEN, AND IT IS UNCLEAR IF IN THIS CASE A FIRE MIGHT HAVE RESULTED, IT WAS DECIDED TO REPORT THIS ISSUE DUE TO THE ADDITIONAL INFORMATION AND NEW DATE OF AWARENESS. IN A WORST-CASE SCENARIO THE RISK OF FIRE AND SERIOUS INJURY CANNOT BE EXCLUDED.

Additional Manufacturer Narrative

E1. A FACILITY CONTACT NAME WAS NOT PROVIDED TO SIEMENS HEALTHCARE FOR REPORTING PURPOSES. H3, H6: MANUFACTURERS PRELIMINARY ANALYSIS: A SHORT CIRCUIT IN THE POWER SUPPLY PLUG IS SEEN AS THE MOST LIKELY CAUSE FOR THE ISSUE. SINCE SYSTEM COMPONENTS ARE UL-CERTIFIED, UNDER NORMAL CIRCUMSTANCES NO FIRE WILL RESULT DUE TO OVERHEATED COMPONENTS. IF THERE IS A SHORT CIRCUIT IN THE PLUG AND THE POWER SUPPLY KEEPS PULSING, EXCESSIVE HEAT CAN BE TRANSFERRED TO THE MONITOR HOUSING FOR AN EXTENDED TIME PERIOD AND CAUSE A FIRE UNDER THESE INCONVENIENT CIRCUMSTANCES. INITIAL CORRECTIVE ACTIONS/PREVENTIVE ACTIONS IMPLEMENTED BY THE MANUFACTURER: THE POWER SUPPLY WAS REPLACED AT THE AFFECTED SITE. EVEN THOUGH NO GENERAL OR SYSTEMATIC PROBLEM WAS IDENTIFIED, IT IS PLANNED TO REPLACE ALL POTENTIALLY AFFECTED MONITOR POWER SUPPLY UNITS IN THE INSTALLED BASE AS A PRECAUTION. THIS ACTION WILL BE REPORTED SEPARATELY TO THE FDA.

Additional Manufacturer Narrative

H11 CORRECTED DATA: H7: "RECALL" AND "REPLACE" WERE CHECKED IN ERROR IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JULY 26, 2023. THESE FIELDS SHOULD HAVE REMAINED BLANK. H10: CLARIFICATION/ADDITIONAL INFORMATION OF STATEMENT REPORTED IN INITIAL REPORT. "EVEN THOUGH NO GENERAL OR SYSTEMATIC PROBLEM WAS IDENTIFIED, IT IS PLANNED TO REPLACE ALL POTENTIALLY AFFECTED MONITOR POWER SUPPLY UNITS IN THE INSTALLED BASE AS A PRECAUTION.": NO REMEDIAL ACTION HAS BEEN INITIATED TO REPLACE ALL POTENTIALLY AFFECTED MONITOR SUPPLY UNITS AS OF THE DATE OF THIS REPORT. REMEDICAL ACTION WILL BE REPORTED SEPARATELY TO THE FDA WHEN RELEASED.