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

Model Number	6888800
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator generated technical error codes indicating disabled valves and a patient category mismatch between breathing and monitoring subsystems.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
Based on technician statement, the issue with mentioned technical errors was not reproduced onsite.The ventilator passed all functional and safety tests and was cleared for clinical use.Technical error idicating disabled valves shall be triggered when a low level of the signal disable_valves.L is detected during a period longer than (11.0 ± 0.1)s.Technical error indicating patient category mismatch between breathing and monitoring subsystems - software error occurred.Patient category was mismatch between breathing and monitoring subsystems (mismatch is between the range of the inspiratory valves and the expected values).Evaluation of device's logs confirm occurrence of claimed technical errors prior to date of event.The root cause to the reported issue has not been determined.
Event or Problem Description
Manufacturer's ref.#: (b)(4).

• Brand Name: BASE UNIT SERVO-U MR
• 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: 19749077
• Report Number: 8010042-2024-01144
• Device Sequence Number: 6579434
• Product Code: CBK
• UDI-Device Identifier: 07325710010518
• UDI-Public: (01)07325710010518(11)200506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 6888800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown