MAUDE Adverse Event Report: Maquet Critical Care AB Base unit Servo-u; Ventilator, Continuous, Facility Use

Model Number	6694800
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	09/10/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient experienced a period of significant hypoxaemia that was not recognized.The reported hypoxaemia was associated with hypoventilation, while the ventilator alarms reportedly had been deactivated.The event resulted in loss of life.Manufacturer¿s ref #: (b)(4).
Additional Manufacturer Narrative
The healthcare facility requested device logs to investigate an apparent change in alarm limits during the relevant date and time period.The available logs were extracted and provided to the healthcare facility for review.Test ventilation was performed using standard settings and parameters, and the ventilator performed as designed.The ventilator was recommended to remain in quarantine pending conclusion of the investigation.The healthcare facility subsequently reported that the alarm level had been altered by an as-yet unidentified individual.Further patient and event information has been requested from the healthcare facility to support completion of the investigation.

• Brand Name: Base unit Servo-u
• Common Device Name: Ventilator, Continuous, Facility Use
• Manufacturer (Section D): Maquet Critical Care AB; roentgenvagen 2; solna
• Manufacturer (Section G): Maquet Critical Care AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 50840658
• Report Number: 3013876692-2026-00107
• Device Sequence Number: 13327901
• Product Code: CBK
• UDI-Device Identifier: 07325710001110
• UDI-Public: (01)07325710001110(11)201202
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026
• Report Date (Section F): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 6694800
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2026
• Device Age: 6 YR
• Date Report to Manufacturer: 09/21/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/21/2026