MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I UNIT BASE; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	6487800
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ventilator failed internal leakage test during pr-use check.Furthermore, the air gas module was contaminated with water.There was no patient involvement.Manufacture's ref.#: (b)(4).
Additional Manufacturer Narrative
The reported ventilator was investigated on-site by the distributor's field service engineer (fse).The fse found traces of liquid contamination inside air gas module.The device will be repaired by replacing the air gas module.The air gas module regulate the inspiratory gas flow and gas mixture.The liquid contamination in the air gas module as previous investigation has shown, had affected the delta pressure transducer on a printed circuit board inside the air gas module.The delta pressure transducer is part of the flow measuring in the gas module.The failure of the delta pressure transducer leads to inaccurate gas flow regulation which will be detected during pre-use check and alarms will be activated if the failure occurs during ventilation.According to the applicable user's manual, maximum levels of water (h2o leass than 7 g/m3) in the supplied gases to the ventilator must not be exceeded.The conclusion is that the device did not fail to meet its specification, as the most probable source of liquid contamination in the air gas module is a contaminated air gas from the hospital's central air gas system.

• Brand Name: SERVO-I UNIT BASE
• 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: 25357474
• Report Number: 8010042-2026-0000714
• Device Sequence Number: 10654315
• Product Code: CBK
• UDI-Device Identifier: 07325710000823
• UDI-Public: (01)07325710000823(11)161115
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123149
• 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: 505
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 6487800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown