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

Model Number	6882000
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On-site investigation was performed by the field service engineer.The pressure transducer test failure was not confirmed in the device logs.Further information and parts have been requested for investigation but have not yet been received.Event site name: (b)(6).Event site postal code: (b)(6).
Event or Problem Description
It was reported that the ventilator failed the pressure transducer test during pre-use check.There was no patient involvement.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
Our field service engineer (fse) has investigated the reported ventilator on-site.The fse replaced the pressure transducer printed circuit board (pcb) to resolve the issue.After the replacement, the ventilator passed all functional and safety tests and was cleared for clinical use.The reported issue was confirmed in provided device's logs.Pressure transducer pcb measures the pressure, conveyed via the pressure tube connected to this block by its differential pressure transducer.With differential reference to the ambient pressure, the output signal is proportional to the measured pressure thus giving a linear measurement in the range -40 cmh2o to +160 cmh2o.A defective pressure transducer may lead to inaccuracy in pressure measurement.Appearance of this failure will be noticed by the user by generated high priority alarms.If present, the fault will be detected during pre-use check.The cause of the reported issue in this customer product complaint has been determined.The issue was related to pressure transducer pcb.
Event or Problem Description
Manufacturer 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: 25372451
• Report Number: 8010042-2026-0000752
• Device Sequence Number: 18794078
• Product Code: CBK
• UDI-Device Identifier: 07325710003114
• UDI-Public: (01)07325710003114(11)230307
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/03/2026

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: 05/14/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown