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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

During investigation on-site performed by our field service engineer, the ventilator failed pressure transducer test during pre-use check.Visual inspection revealed moisture/water traces inside the o2 gas module.The conclusion was that the reported failed pressure transducer test was due to water traces inside the o2 gas module.The device logs were not received and no parts have been returned for investigation.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 most probable source of moisture/water into a gas module is moisture from the hospital's gas supply system and/or external compressor.

Event Description

It was reported that the ventilator failed pressure transducer test during pre-use check.The o2 gas module was contaminated with water/moisture.There was no patient involvement.Manufacturer's ref #: (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: 11371206
• MDR Text Key: 233245098
• Report Number: 8010042-2021-00466
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2021

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
• Device Operator: Health Professional
• Device Model Number: SERVO-S
• Device Catalogue Number: 6640440
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1