MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA DVE/MOVITA; MEDICAL GAS AND VACUUM SYSTEMS

Catalog Number	M35054
Medical Device Problem Codes	Structural Problem (2506); Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the axle between the support arm and the flange tube of the movita supply unit had come loose on one side, causing the supply unit to tilt.When attempting to unload and release the axle, the attached änesthesia device (perseus 500) jumped out of its mounting spigot and fell over.The anesthesia device continued to function even in this situation.No serious injury occurred; one person suffered a slight hematoma on the foot.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Additional Manufacturer Narrative
For the investigation, the information and photos provided as well as product-relevant documents and instructions were evaluated.Further clarifying information about what happened was requested but was not provided.The support axle at the end of the lifting arm mounting rocker with the connection to the supply unit is secured against axial displacement with a washer and screw combination.Due to the forces involved in moving the lift arm, it is possible for a washer and bolt combination to come loose.To avoid this, the fastening of the screw-washer combination has a torque of 2.5 nm and loctite 221 (screw locking) is used.In the present case, it could not be clarified whether in the affected system, insufficient torque and/or a lack of screw locking caused the screw to loosen during the movement of the lifting arm.The affected device is from 2016 and was not serviced by dräger during this time.If the screw loosens completely, this can cause the axle to come out of alignment on one side.The weight of the column causes the axle and the column to tilt.The inclination is visible to the user so that the user can take necessary measures.The angle of inclination is not such that equipment or material placed on shelves can fall.The column is not expected to fall because the axle gets jammed in the support arm on the opposite side of the bearing when it slides sideways.The tightness of the screw and washer is checked during regular maintenance.It is unlikely that the perseus will fall over or become uncoupled simply because the axle has slipped out without further action.It is likely that when the ceiling supply unit was unloaded, the perseus was unintentionally lifted/released from the mounting pins in the open device holder of the dve, so that the perseus was no longer coupled to the dve.This allowed the perseus to tip over forward as soon as it touched the ground or an object.The affected system was repaired by dräger service and is now in use again.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 axle between the support arm and the flange tube of the movita supply unit had come loose on one side, causing the supply unit to tilt.When attempting to unload and release the axle, the attached änesthesia device (perseus 500) jumped out of its mounting spigot and fell over.The anesthesia device continued to function even in this situation.No serious injury occurred; one person suffered a slight hematoma on the foot.

• Brand Name: DVE/MOVITA
• Common Device Name: MEDICAL GAS AND VACUUM SYSTEMS
• 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: 18063129
• Report Number: 9611500-2023-00393
• Device Sequence Number: 17998973
• Product Code: FQO
• UDI-Device Identifier: 04048675228059
• UDI-Public: (01)04048675228059(11)161101(93)M35054-32
• Combination Product (Y/N): N
• PMA/510(K) Number: D167937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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 Catalogue Number: M35054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2016
• 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