MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FGSP; 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
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 investigation is still on-going.The results will be provided with a follow-up report.
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.The side slide was replaced and the screws reinforced.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 additionally, 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.In total, 3 similar cases have been reported to us from this hospital.The first reported complaint revealed that the 4 screws originally belonging to this unit were available at customer site but were not installed.Acc.To specification, the screws are installed when the device is delivered.It is therefore not possible to determine why the screws were available at the customer premises but were not installed to secure the drawer.It is unknown what happened between delivery of the device and the event.A manufacturing error can be ruled out as the error pattern of drawers falling out has only occurred in this hospital since the design change in 2014.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.Finally, it can be assumed that the error mechanism as described above was also root cause for the current case.The drawer is used to store additional equipment in it; a malfunction like reported does not compromize primary operating functions of the anesthesia workstation.
Event or Problem Description
It was reported that the bottom drawer of the fabius gs premium was falling out.No injury reported.

• Brand Name: FGSP
• 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: 20721670
• Report Number: 9611500-2024-00517
• Device Sequence Number: 19796222
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown