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

Model Number FLOW-I C20

Device Problem Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/13/2023

Event Type  Injury  

Event Description

It was reported that while the patient was connected to the anesthesia system in afgo (additional fresh gas outlet) mode, no flow was delivered to the patient.The patient was connected to the afgo outlet via a nasal cannula.The patient saturation temporarily decreased to 79 %.The final patient outcome was no injury.Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-I
• 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: 18037943
• MDR Text Key: 326948530
• Report Number: 3013876692-2023-00051
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6888520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2023
• Distributor Facility Aware Date: 10/14/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Date Manufacturer Received: 10/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening