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	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator generated a technical error code indicating a software error.There was no patient harm.Manufacturer's ref #: (b)(4).
Additional Manufacturer Narrative
The field service engineer (fse) has investigated the reported ventilator on-site.The fse replaced the control printed circuit board (pcb) to resolve the issue and sent back for further investigation.After the replacement, the ventilator passed all functional and safety tests and was cleared for clinical use.The provided logs confirm the reported issue.The returned control pcb has been tested in a ventilator.It passed the pre-use check.No issues were found during ventilation for one week.It passed another pre-use check after ventilation without any issue.The control pcb is a part of subsystem breathing bre.Main functions are responsibility for the patient treatment, i.E.How to regulate the inspiratory and expiratory gas flow.Includes a memory backup battery.The conclusion is that the reported ventilator has failed to meet its specifications during the reported event.However, the reported issue could not be reproduced at the manufacturer site.Therefore, it was not possible to confirm if the replaced pcb was faulty.A correction of field # d1 brand name, # d4 version or model #.D1 ¿ brand name ¿ previous brand name: servo-u mr.Corrected brand name: base unit servo-u mr.D4 ¿ version or model # - previous version or model #: servo-u mr.Corrected version or model #: 6888800.D4 ¿ unique identifier (udi) # - previous unique identifier (udi) #: missing.Corrected unique identifier (udi) #: (b)(4).According to the corrected udi number, the manufacturer date has been corrected from 02/16/2021 to 02/12/2021.
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: 18775576
• Report Number: 8010042-2024-00358
• Device Sequence Number: 15022993
• Product Code: CBK
• UDI-Device Identifier: 07325710010518
• UDI-Public: (01)07325710010518(11)210212
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/26/2024

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
• Device Catalogue Number: 6888800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown