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

Model Number	6640440
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the technician's statement, the device was repaired by third-party.There was no on-site visit by our technician.Alarm o2 concentration low is activated when measured o2 concentration is below the set value by more than 5 volume % or concentration is below 18 volume % which is independent of settings.There are two main reasons for this alarms: gas delivery error (wrong gas concentration is delivered from the system, but the gas concentration is measured correctly) or measurement error (correct gas concentration is delivered from the system, but the gas concentration is measured incorrectly).O2 concentration low alarm may in some cases indicating that the ventilation have been insufficient due to gas delivery error, which represent a reportable event.Unfortunately, the device's logs, no further analysis has been possible.No more information was provided and it is impossible to know what was the cause of the issue.Telephone site number: (b)(6).
Event or Problem Description
It was reported that the ventilator generated an alarm of low o2 concentration.There was no patient harm.Manufacturer's ref#: (b)(4).

• Brand Name: SERVO-S BASE UNIT
• 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: 25486098
• Report Number: 8010042-2026-0000783
• Device Sequence Number: 10448970
• Product Code: CBK
• UDI-Device Identifier: 07325710001127
• UDI-Public: (01)07325710001127(11)210316
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: 6640440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown