INFINITY ACUTE CARE SYSTEM (M540)
Report
- Report Number
- 1220063-2023-00008
- Event Type
- Malfunction
- Date Received
- April 5, 2023
- Date of Event
- February 22, 2023
- Report Date
- September 29, 2023
- Manufacturer
- DRÄGERWERK AG & CO. KGAA
- Product Code
- MHX
- UDI-DI
- 04049098054409
- PMA / PMN Number
- K203088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.
THE CITED POWER SUPPLY, WHICH WAS INSTALLED AT THE CUSTOMER SITE IN 2014, WAS REPLACED BY THE HOSPITAL'S BIOMED AND RETURNED TO DRAEGER FOR FURTHER EVALUATION. IT WAS FOUND THAT THE UNIT WOULD NOT POWER UP. NO SIGNS FOR A THERMAL EVENT THAT MAY HAVE CAUSED SMOKE COULD BE FOUND; NO CHARRING OF ELECTRONIC PARTS WAS PRESENT AND, NO BURNING SMELL WAS OBSERVED ANYMORE. THE POWER SUPPLY IS DESIGNED IN ACCORDANCE TO THE REQUIREMENTS LAID DOWN IN IEC 60601-1-1; IN PARTICULAR IT IS MADE FROM MATERIALS THAT ARE SELF-EXTINGUISHING TO MINIMIZE THE RISK OF IGNITION. THIS HAS OBVIOUSLY WORKED AS INTENDED - IT CANNOT BE EXCLUDED THAT E.G. THE BLOWING OF AN ELECTROLYTIC CAPACITOR HAS INDEED PRODUCED A BURNING SMELL THAT COULD BE NOTED FOR A SHORT PERIOD OF TIME BUT THE ENERGY SUPPLY WAS CUT-OFF FAST BEFORE AN IGNITION COULD DEVELOP. THE MALFUNCTION OF THE POWER SUPPLY WILL RESULT IN A LOSS OF NETWORK CONNECTION TO THE CENTRAL MONITORING STATION AND TRIGGER A DEDICATED ALARM. PATIENT MONITORING WILL NOT BE INTERRUPTED SINCE THE BED-SIDE MONITOR IS EQUIPPED WITH BATTERIES AS A BACK-UP ENERGY SOURCE. THE POWER SUPPLY WAS APPROXIMATELY 9 YEARS OLD AT THE TIME OF THE FAILURE, THERE WAS NO INDICATION OF A MANUFACTURING DEFECT AND THE OVER-ALL FIELD FAILURE RATE OF THE PRODUCT IS INCONSPICUOUS. AN IN-DEPTH INVESTIGATION OF THE EXACT FAILURE MODE WAS THUS NOT CONSIDERED NECESSARY.
IT WAS REPORTED THERE WAS A BURNING SMELL COMING FROM THE P2500 [POWER SUPPLY] DURING USE IN A PATIENT CARE ENVIRONMENT. IT WAS NOTED BY THE HOSPITAL BIOMED THAT THE ODOR WAS THAT OF A BURNT OUT ELECTROLYTIC CAPACITOR. THE WORK ORDER COMPLETED BY THE CLINICAL STAFF MEMBER STATED ¿HEAVY SMELL OF BURNING WIRES, SPARKING - URGENT - SHUTTING DOWN ENTIRE FLOOR, TAKING PATIENTS OUT¿. THIS WAS CLARIFIED AS 3 PATIENTS WERE REMOVED FROM THE UNIT. WHEN THE BIOMED ARRIVED THERE WAS NO FIRE OR SMOKE SEEN. THE CITED POWER SUPPLY WAS REPLACED. NO PATIENT OR STAFF INJURY OCCURRED. THE INFINITY ACUTE CARE SYSTEM (IACS) INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR. THE INFINITY P2500 IS THE DEDICATED POWER SOURCE AND NETWORKING HUB FOR THE INFINITY M540 PATIENT MONITOR AND INFINITY MEDICAL COCKPIT. THE P2500 IN THIS CASE IS PART NUMBER MS22277 / SERIAL NUMBER (B)(4).
IT WAS REPORTED THERE WAS A BURNING SMELL COMING FROM THE P2500 [POWER SUPPLY] DURING USE IN A PATIENT CARE ENVIRONMENT. IT WAS NOTED BY THE HOSPITAL BIOMED THAT THE ODOR WAS THAT OF A BURNT OUT ELECTROLYTIC CAPACITOR. THE WORK ORDER COMPLETED BY THE CLINICAL STAFF MEMBER STATED ¿HEAVY SMELL OF BURNING WIRES, SPARKING - URGENT - SHUTTING DOWN ENTIRE FLOOR, TAKING PATIENTS OUT¿. THIS WAS CLARIFIED AS 3 PATIENTS WERE REMOVED FROM THE UNIT. WHEN THE BIOMED ARRIVED THERE WAS NO FIRE OR SMOKE SEEN. THE CITED POWER SUPPLY WAS REPLACED. NO PATIENT OR STAFF INJURY OCCURRED. THE INFINITY ACUTE CARE SYSTEM (IACS) INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR. THE INFINITY P2500 IS THE DEDICATED POWER SOURCE AND NETWORKING HUB FOR THE INFINITY M540 PATIENT MONITOR AND INFINITY MEDICAL COCKPIT. THE P2500 IN THIS CASE IS PART NUMBER MS22277 / SERIAL NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1799007 | INFINITY ACUTE CARE SYSTEM (M540) | PHYSIOLOGICAL MONITORING SYSTEMS | MHX | DRÄGERWERK AG & CO. KGAA | MS20401 | 04049098054409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | NA. |