MAUDE Adverse Event Report: MAQUET GMBH MEERA MOBILE OPERATING TABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	720001B0
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.The full unique identifier (udi)# information is not available since the device was manufactured before 09/24/2022.E1 event site name: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our mobile tables - 720001b0 - meera eu without auto drive.As it was stated, during a percutaneous nephrolithotomy surgical procedure with an anesthetized patient on the table in the lithotomy position, the attending technician used the remote control to return the table to the "0 position¿.Unexpectedly, the table dropped down abruptly, causing the patient to fall to the ground.The floor was damaged due to the leg section hitting the ground and coming surgery postponed.The operation was completed and the patient was shifted to post-recovery.During a service visit on site, the functionality of the operating table was checked.All positions were working and no error was displayed on the screen of the hand control.We decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the operating table resulting in the patient¿s fall, was to reoccur.

• Brand Name: MEERA MOBILE OPERATING TABLE
• Common Device Name: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: diana gutekunst ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 22076339
• Report Number: 8010652-2025-0000023
• Device Sequence Number: 20964994
• Product Code: FQO
• UDI-Device Identifier: 04046768124332
• UDI-Public: (01)04046768124332
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: Other
• Device Model Number: 720001B0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 51 KG