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

Model Number	6481779
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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).
Event or Problem Description
Ref.#: (b)(4).
Additional Manufacturer Narrative
The field service engineer (fse) has investigated the reported compressor on-site.The drainage valve was replaced to resolve the issue and sent back for further investigation.After the replacement, the compressor passed all functional and safety tests and was cleared for clinical use.The returned drainage valve has been tested in a compressor, then the compressor was connected to a ventilator.The compressor after that, was started and the ventilator was set on ventilation for 4 hours.It was not possible to reproduce any issue, as the valve of the drainage valve opened every 30 seconds and it blew out the condensed water to the drainage bottle.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 conclusion is that the reported compressor 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 drainage valve was faulty.

• 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: 21737961
• Report Number: 8010042-2025-0000508
• Device Sequence Number: 12945287
• 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): 04/01/2025

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: 03/25/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown