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

Model Number SERVO-S

Device Problems Contamination /Decontamination Problem (2895); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The ventilator was investigated on-site by our field service engineer.The ventilator failed flow transducer test during pre-use check.The inspection revealed that moisture/water traces inside the air gas module.The provided pictures confirmed the water traces in the air gas module.The provided logs confirmed the reported flow transducer test failure.The conclusion was that the reported failure was resolved by replacing the air gas module.Moisture/water in supply gases into a gas modules can cause failure which might lead to a stop of ventilation or high pressures.Alarms will be generated.According to the user's manual, maximum levels of water, (h2o < 7 g/m3) in the supplied gases to the ventilator must not be exceeded.The source of moisture/water into a gas module is moisture from external compressor.Since no parts have been returned for investigation, the root cause of the reported event has not been determined.

Event Description

It was reported that the ventilator failed flow transducer test during pre-use check.The air gas module was contaminated with water.There was no patient involvement.(b)(4).

• Brand Name: SERVO-S
• Type of Device: 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: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11684577
• MDR Text Key: 245980925
• Report Number: 8010042-2021-00874
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-S
• Device Catalogue Number: 6640440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1