MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGICAL MONITORING SYSTEMS

Model Number	MS20401
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
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).
Event or Problem Description
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).
Additional Manufacturer Narrative
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.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Common Device Name: PHYSIOLOGICAL MONITORING SYSTEMS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 16686670
• Report Number: 1220063-2023-00008
• Device Sequence Number: 17982595
• Product Code: MHX
• UDI-Device Identifier: 04049098054409
• UDI-Public: 04049098054409
• Combination Product (Y/N): N
• PMA/510(K) Number: K203088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS20401
• Device Catalogue Number: MS20401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown