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

Model Number SERVO-I

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

According to the customer report, presence of water/moisture spill was confirmed in the ventilator's gas module.The ventilator could be used again after drying the gas module.No parts were replaced and no ventilator logs were provided.Water/moisture 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.The root cause of the reported event has not been determined.Based on the above information this complaint will be closed.

Event Description

It was reported that water has entered into the ventilator's gas module.There was no patient harm.Manufacturer's ref #: (b)(4).

• Brand Name: SERVO-I
• 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: 11331387
• MDR Text Key: 232029067
• Report Number: 8010042-2021-00396
• 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: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2021

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-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2015
• 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