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

Model Number	8607300
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the ventilator stopped during use of the device.It was mentioned that no consequences to the patient have resulted from that; patient support was done in maunal ventilation.
Event or Problem Description
It was reported that the ventilator stopped during use of the device.It was mentioned that no consequences to the patient have resulted from that; patient support was done in manual ventilation.
Additional Manufacturer Narrative
The device was inspected by a dräger service engineer.Based on the findings of an initial log file analysis it was decided to replace the upper piston diaphragm and the pump that generates the auxiliary vacuum pressure.The device was tested afterwards, found fully compliant to specifications and could be returned to use.A detailed log file analysis carried out by the manufacturer confirms the validity of the initial expertise and the appropriateness of the repair measure.The log contains entries demonstrating that the driving current for the ventilator motor went repeatedly up to a range where it will be switched-off by the supervisor function of the software to prevent from damages to the ventilator unit.The shut-down of ventilation was accompanied by a corresponding alarm; manual ventilation with the built-in breathing bag remains possible then.A plausible explanation would be that the upper piston diaphragm became dislodged or wrinkled and hindered the piston in its movement which resulted in an increase of the motor current above the allowed threshold.The piston diaphragm is kept in place by a vacuum pressure generated by a dedicated pump - it would be feasible that a decrease in the vacuum pressure contributed to a dislocation or wrinkling of the diaphragm.Finally, it can be concluded that the device has responded as designed upon this particular error condition; the device was ready to use again after all parts had been replaced that can be put in causal connection to the symptoms.

• Brand Name: FABIUS MRI
• 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
• MDR Report Key: 15291348
• Report Number: 9611500-2022-00218
• Device Sequence Number: 20624815
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)211215(17)220307(93)8607300-49
• Combination Product (Y/N): N
• PMA/510(K) Number: K072884
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 8607300
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2021
• 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: N/A.; N/A.
• Patient Sex: Unknown