MAUDE Adverse Event Report: DRAEGER INC. DELTA; PHYSIOLOGIC MONITORING SYSTEM

Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the delta power supply unit caught fire when plugged into the main power supply.The power supply unit and docking station were mounted on a trolley, with the mains plug facing upwards.The transport trolley was connected to a patient at the time of the incident, and the delta was connected to the power supply to bridge a waiting period.The plug of the power supply unit was connected to a multiple socket on the trolley, and there was a bang and a "jet of flame" in the area of the power supply unit.No patient or user injury or death was reported.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
The customer reported that the delta power supply unit caught fire when plugged into the main power supply.The power supply unit and docking station were mounted on a trolley, with the mains plug facing upwards.The transport trolley was connected to a patient at the time of the incident, and the delta was connected to the power supply to bridge a waiting period.The plug of the power supply unit was connected to a multiple socket on the trolley, and there was a bang and a "jet of flame" in the area of the power supply unit.No patient or user injury or death was reported.
Additional Manufacturer Narrative
It was reported to draeger that the delta power supply became charred and caught fire when it was plugged into the main ac power source.Visual inspection of the power supply confirmed that a thermal event had occurred, caused by the energy release during a short circuit.The dräger service engineer at the customer's site reported that the cited power supply was mounted on a transport trolley with the ac main power connection facing upwards.In an interview with the biomedical engineer in this ward, both sides concluded that disinfectant liquid had penetrated the (ac main power) plug connection and caused a short circuit which damaged the device.It could be confirmed that the duration of the event was only 1 or 2 seconds until the fuse tripped.The trolley installation wasn¿t made by dräger.A new power supply was handed over to the customer.Dräger finally concludes that the unfavorable way of mounting of the equipment on the trolley contributed to the event.Most likely, the presence of disinfectant liquid has caused a short circuit or dried residues of it had formed a creeping path with the same consequence.The delta monitor and the associated universal power supply is designed to meet the iec 60601-1 standard for basic safety and essential performance of medical electrical equipment and the risk of fire is minimized because the used materials are classified as ul 94 v-0 or better ¿ the ignition of the material will extinguish by itself as soon as the energy supply is cut off (tripping fuse opens the electric circuit).There is no other similar event known.

• Brand Name: DELTA
• Common Device Name: PHYSIOLOGIC MONITORING SYSTEM
• Manufacturer (Section D): DRAEGER INC.
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: 3135 quarry road; telford, PA 18969 ; 2156602400
• MDR Report Key: 19311689
• Report Number: 1220063-2024-00056
• Device Sequence Number: 3102640
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: 04049098004152
• Combination Product (Y/N): N
• PMA/510(K) Number: K152407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: N/A.; N/A.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown