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

Model Number	8607000
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 bottom drawer of the fabius gs premium was falling out.No injury reported.
Additional Manufacturer Narrative
The device was subject to an on-site examination.The reported issue could be confirmed - the drawers were not secure and were falling out of unit.They were reinforced with screws provided by the customer which were originally from the unit.Afterwards, the device was tested and confirmed to be operating per manufacturer¿s specification.In 2014 the drawer design was improved.Telescopic slides with threaded holes instead of brackets are installed and additioally, each drawer is fixed with four screws to the slides to prevent pulling out.The involved fabius was manufactured in 2018 so is already provided with the improved design.It is unknown why the screws to secure the drawer were obviously not installed as they were provided by the customer after the drawer fell out.A manufacturing error can be ruled out.This is further supported by the fact that the symptoms of drawers falling out have only occurred in this hospital since the design change in 2014.In total, 3 similar cases were reported to us from this hospital.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The drawer is used to store additional equipment in it; a malfunction like reported does not compromize primary operating functions of the anesthesia workstation.Finally, it can be concluded that not installed screws have caused the drawer to fall out.The screws are installed when the devices are delivered.It is therefore not possible to determine why the screws were not installed at the customer and was happened between delivery of the device and the event.
Event or Problem Description
It was reported that the bottom drawer of the fabius gs premium was falling out.No injury reported.

• Brand Name: FABIUS GS PREMIUM
• 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: 20721679
• Report Number: 9611500-2024-00516
• Device Sequence Number: 3851284
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)181207(93)8607000-72
• Combination Product (Y/N): N
• PMA/510(K) Number: K011404
• 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): 01/14/2025

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: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2018
• 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
• Patient Sex: Unknown