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

Model Number 6887900

Device Problem Output Problem (3005)

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

Event Date 04/06/2024

Event Type  malfunction  

Event Description

It was reported that the anesthesia system made a loud clicking noise and did not deliver breaths.Airway pressure alarms were generated.There was no patient harm.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On-site investigation was performed by our field service engineer.The claimed issue was not reproduced during troubleshooting.Based on provided information after switching to manual ventilation and back to controlled mode, the issue did not reoccur and device was working correctly.Patient was connected back to anesthesia workstation and case was continue without interruption.Reported issue can be confirmed in provided device's logs.Evaluation of the logs showed that on the date of event system checkout (sco) was passed prior to the case.The leakage check was also performed.After case device also passed system checkout.The most probable cause of the high airway pressure alarm and clicking noise during case was the lung compliance was lower than expected causing the pressure regulated alarms and clicking noise was caused by safety valve being open due to activated high airway pressure alarm.Our conclusion is that changing the ventilation mode solved the reported failure.A correction of fields #d1 brand name, #d4 version or model#, #d4 unique identifier (udi) #, #h4 device manufacture date, #h6 adverse event problem and evaluation codes - health effect ¿ impact codes.D1 - brand name - previous brand name: flow-e, corrected brand name: flow-e anesthesia system.D4 - version or model # - previous version or model #.Flow-e.Corrected version or model #: 6887900.D4 ¿ unique identifier (udi) # - previous unique identifier (udi) #: missing, corrected unique identifier (udi) #: (b)(4).H4 - device manufacture date - previous manufacture date: 11/01/2021, corrected manufacture date: 10/21/2021.H6 - adverse event problem and evaluation codes - health effect ¿ impact codes - previous health effect ¿ impact codes: missing, corrected health effect ¿ impact codes: no health consequences or impact|||2199.

Event Description

Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-E ANESTHESIA SYSTEM
• Type of Device: GAS-MACHINE, ANESTHESIA
• 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: 19199709
• MDR Text Key: 341594772
• Report Number: 8010042-2024-00675
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)211021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2024

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: 6887900
• Device Catalogue Number: 6887900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 06/27/2024
• Supplement Dates FDA Received: 07/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1