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

Model Number	6481779
Medical Device Problem Codes	Moisture or Humidity Problem (2986); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred on the hong kong 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 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's drainage valve was found defective.There was no patient harm.Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.According to received information in service report, replacement of the drainage valve solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.The issue has been resolved and the device has been returned to use in good working condition.The drainage valve is powered with 12 v and electrically controlled by the pc board.The purpose of the drainage valve is to remove water collected in the water separator at regular intervals.The valve is closed in non-activated condition.During operation, the valve will be activated (open) for approx.0.5 seconds twice every minute by the timing circuit on the pc board.When the valve opens, the water collected in the water separator will be transported to the drainage bottle.The faulty drainage valve may lead to moisture air entering the air gas module.Water in the air gas module may damage the air gas module.Unfortunately, the claimed part has not been available for the further analyze of the issue.The cause of the issue was related to drainage valve.
Event or Problem Description
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: 21395975
• Report Number: 8010042-2025-0000260
• Device Sequence Number: 15421668
• Product Code: BTI
• UDI-Device Identifier: 07325710001653
• UDI-Public: 07325710001653
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 02/17/2025

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: 6481779
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown