MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number C30

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the anesthesia workstation generated alarms for high airway pressure during patient treatment.There was no patient harm.(b)(4).

Event Description

Manufacturer's ref #: (b)(4).

Manufacturer Narrative

It was reported that there was a moisture build-up in the patient tubings during low-flow anesthesia during a surgery lasting more than one hour.It was reported that alarms for airway pressure: high, were generated but we have not received any device logs to confirm this.No issues have been found during examination of the anesthesia workstation.A moisture build-up in the patient tubings is a normal phenomenon when running low or minimal flow anesthesia.During low or minimal flow anesthesia, there is a high degree of re-breathing and then a high portion of the moisture from the exhaled air from the patient stays in the circuit.Water is a natural bi-product when co2 is absorbed.It is a physical process and is not related to any malfunction of the anesthesia workstation.

• Brand Name: FLOW-I C30
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8456205
• MDR Text Key: 140286206
• Report Number: 8010042-2019-00210
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C30
• Device Catalogue Number: 6677300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1