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

Model Number	6487800
Medical Device Problem Codes	Failure of Device to Self-Test (2937); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator failed flow transducer test and safety valve test during pre-use check.Moreover, the ventilator generated a technical error code indicating error in the internal memory.There was no patient involvement.Manufacturer's ref.#: (b)(4).

• Brand Name: SERVO-I 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: 25558136
• Report Number: 8010042-2026-0000830
• Device Sequence Number: 10250405
• Product Code: CBK
• UDI-Device Identifier: 07325710000823
• UDI-Public: (01)07325710000823(11)210518
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123149
• 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): 06/19/2026

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: 6487800
• 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: 05/26/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown