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

Catalog Number	G16805
Medical Device Problem Codes	Structural Problem (2506); Detachment of Device or Device Component (2907); Unintended Movement (3026); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Event or Problem Description
It was reported that in room 366, a drawer came loose from the column and fell to the floor.No consequences have been reported.However, in case of recurrance it cannot be excluded that the patient or user will be injured by the drop of the device.
Event or Problem Description
It was reported that in room 366, a drawer came loose from the column and fell to the floor.No consequences have been reported.However, in case of recurrance it cannot be excluded that the patient or user will be injured by the drop of the device.
Additional Manufacturer Narrative
The investigation was based on the provided information by dräger service.The dräger service technician onsite examined the affected dve and other dve movita devices at the customer site.Dräger technician onsite noticed that the screws were loose and that was the cause of the fall.It was reported that the installation was performed by a third party, there was no handoff documentation from the third party.After the complaint was reported, all devices were inspected according to manufacturer specs.The drawer is mounted with a fix angle set to the movita column standard rails.6 screws are used to mount the 2 clamping profiles to the fix angle.This is done during first assembly in the hospital according to supplement for the instructions for use and checked by test instructions ¿tightening torque of screws securing installed accessories¿.For maintenance a general check for accessories is done according to servicecard ipm.According to the investigation results, it seems like the drawer was not fitted correctly.The screws on the drawers were not initially tightened properly during installation.Neither patient nor user health consequences reported.Detachment of parts can only happen during handling and will be obvious to the user.No patient should be located under the drawer according to ifu.Furthermore, the loosening of screws is not a sudden process.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 18684063
• Report Number: 9611500-2024-00050
• Device Sequence Number: 6395859
• Product Code: FQO
• UDI-Device Identifier: 04048675017684
• UDI-Public: (01)04048675017684(11)210910(93)G16805-60
• Combination Product (Y/N): N
• PMA/510(K) Number: D167937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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 Catalogue Number: G16805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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: NA.; NA.
• Patient Sex: Unknown