MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS; ANESTHESIA UNITS

Model Number	8604700
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that the ventilator sounds louder than normal.Based on the log analysis a ventilator failure occurred due to a negative airway pressure.No injury reported.
Additional Manufacturer Narrative
It was reported that the ventilator sounds louder than normal.On the date of event (2024-07-08) an entry indicating a negative airway pressure was found.In such case, the ventilator is temporarily stopped as a precaution while the ¿ventilator fail¿ alarm is given.Since the log entry was only found once on the reported date of event, it was concluded that most likely a patient activity, such as coughing, was the root cause.Dräger finally concludes that the device behaved as specified upon the detected pressure situation and the device alarmed accordingly to alert the user.During inspection on site the reported louder sound could be traced back to the bearings of the motor.Therefore, it was recommended by the technician to replace the ventilator assembly and ventilator lid.In the course of additional questions we were informed that the customer plans to retire the unit as it is already 21 years old so that no further repair actions are planned.The identified wear and tear effects responsible for the louder sound are not in context with the found error entry indicating a negative airway pressure.For both topics, the number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that the ventilator sounds louder than normal.Based on the log analysis a ventilator failure occurred due to a negative airway pressure.No injury reported.

• Brand Name: FABIUS GS
• Common Device Name: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 19881731
• Report Number: 9611500-2024-00323
• Device Sequence Number: 15226013
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)210922(93)8607300-49
• Combination Product (Y/N): N
• PMA/510(K) Number: K072884
• Number of Events Summarized: 1
• Summary Report (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): 09/17/2024

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
• Device Model Number: 8604700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2021
• 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.; NA.
• Patient Sex: Unknown