MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB COMPRESSOR MINI 115V 60HZ; COMPRESSOR, AIR, PORTABLE

Model Number	6481787
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on technician statement water has been found in the gas module of connected ventilator.Dust filter was cleaned properly.The issue has been resolved and the device has been returned to use in good working condition.The compressor¿s dust filter, made of a synthetic material, is mounted on the rear panel of the unit.The purpose of this filter is to clean the cooling air forced through the unit by the radial fan and the two fans in the compressor.The unit should be cleaned at least every 200 hours of operation or once a week when in continuous use.If the compressor is used in a dusty environment the dust filters must be cleaned daily.The recommended methods are detailed described in manuals and indicates that the dust filters may be rinsed in water and the user should check if the filters are free of excess water before returning them to the compressor.The user has been informed, that the dust filter should be cleaned regularly to avoid similar scenario in the future.Water in the air gas module may damage the air gas module.The cause of the issue was related to dust filter.This event occurred on the chinese market on a significantly similar device to ¿compressor mini 115v 60hz¿ which is sold in the us.Therefore, for d4 unique identifier (udi) #, primary di number has been used from compressor mini 115v 60hz.Provided in initial report: d4 serial # and h4 device manufacture date, correspond to device involved in the event, which is "compressor mini 230v¿.
Event or Problem Description
It was reported that the compressor malfunctioned due to excessive dust accumulation caused by the dust filter.There was no patient harm.Manufacturer's ref.#: (b)(4).

• Brand Name: COMPRESSOR MINI 115V 60HZ
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• 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: 23847827
• Report Number: 8010042-2025-0001866
• Device Sequence Number: 21225563
• Product Code: BTI
• UDI-Device Identifier: 07325710001653
• UDI-Public: 07325710001653
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: 6481787
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown