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

Model Number	6487800
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator generated technical error code indicating power error.There was no patient involvement.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
The reported ventilator was investigated on-site by the third-party field service engineer (fse).The issue occurred during standby.It was stated that expiratory channel printed circuit board (pcb) is defective.The device's logs and claimed parts were not provided for further analysis.Power error (power failure minus 12 volts too high alarm) shall be triggered when -12 v supply is more than -10.8 v for more than three seconds.The monitoring subsystem shall when the -12 v supply is more than -10.8 v for more than three seconds activate the signal disable and deactivate the disable signal when the supply is less than -10.8 v.Expiratory channel printed circuit board (pcb) contains electronics including microprocessor for handling of expiratory flow measurement performed by the flowmeter inside the cassette, all electronic connections to and from the cassette, expiratory valve control, safety valve control, temperature monitoring and also holders and electrical connectors for the expiratory and inspiratory pressure transducer boards.The cause of the claimed issues in this customer product complaint has been determined.The issues were related to expiratory channel pcb.

• 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: 25662592
• Report Number: 8010042-2026-0000873
• Device Sequence Number: 20243550
• Product Code: CBK
• UDI-Device Identifier: 07325710000823
• UDI-Public: (01)07325710000823(11)160823
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown