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	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred on the indian 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 50hz¿.
Event or Problem Description
It was reported that water was coming from the compressor and affected ventilator's air gas module.There was no patient harm.Manufacturer's ref #: (b)(4).
Event or Problem Description
Manufacturer's ref #: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed.The claimed issue was reproduced during troubleshooting.According to received information in service report, replacement of the thermoelectric cooler solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.The compressor mini is equipped with a thermoelectric cooler.The thermoelectric cooler is a self-contained unit including a 12 v peltier device which has one cool side and one warm side.The compressed air is supplied to the cool side of the peltier device.When the temperature of the compressed air is lowered, moisture that remains in the air is partly transformed into water by condensation.This water is then collected in the water separator connected to the outlet of the thermoelectric cooler.Water in the air gas module may damage the air gas module.The issue may lead to stop of ventilation or high pressure.Unfortunately, the claimed part has been not available for the further analyze of the issue.The cause of the issue was related to thermoelectric cooler.

• 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: 22095066
• Report Number: 8010042-2025-0000825
• Device Sequence Number: 12777538
• Product Code: BTI
• UDI-Device Identifier: 07325710001653
• UDI-Public: 07325710001653
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown