MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB BASE UNIT, SERVO-AIR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	6882000
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was not reproduced during troubleshooting.According to received information in service report, no parts were replaced to solve the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.Alarm o2 concentration low is activated when measured o2 concentration exceeds the set value by more than 5 vol.% below the set concentration value.The alarm is delayed 40 seconds after changing the o2 concentration setting.There is also an absolute minimum alarm limit of 18% o2 which is independent of operating settings.There can be two reasons for this alarm: gas delivery error and measurement error.Gas delivery error is when wrong gas concentration is delivered from the system, but the gas concentration is measured correctly.Measurement error is when correct gas concentration is delivered from the system, but the gas concentration is measured incorrectly.Incorrect o2 concentration delivered to the patient may in some cases indicating that the ventilation have been insufficient due to gas delivery error, which represent a reportable event.The reported issue was confirmed in provided device's logs.The cause of the reported event has not been determined.
Event or Problem Description
It was reported that the ventilator generated an alarm indicating low o2 concentration.There was no patient harm.Manufacturer's ref.#: (b)(4).

• Brand Name: BASE UNIT, SERVO-AIR
• 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: 25618449
• Report Number: 8010042-2026-0000866
• Device Sequence Number: 10195115
• Product Code: CBK
• UDI-Device Identifier: 07325710003114
• UDI-Public: (01)07325710003114(11)251103
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K192604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: 6882000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown