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	05/21/2026
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 part was replaced.The ventilator passed all functional and safety tests and was cleared for clinical use.Reported error indicates that the safety valve is detected as open without fulfilled opening conditions.A safety valve open alarm shall be triggered when a low level of the signal safety valve closed is detected for more than 8 sec and before 10 sec.Recommended action in case of technical error occurrence is to check inspiratory channel or safety valve pull magnet or expiratory channel board.Occurrence of reported error may lead to stop of ventilation.The reported issue was confirmed in provided device's log.The cause of the failure was not established.
Event or Problem Description
It was reported that the ventilator generated a technical error code indicating an open safety valve.There was no patient harm.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: 25545979
• Report Number: 8010042-2026-0000823
• Device Sequence Number: 5585543
• Product Code: CBK
• UDI-Device Identifier: 07325710000823
• UDI-Public: (01)07325710000823(11)170207
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: 05/22/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown