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

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that during patient treatment, while gently pulling the non re-usable patient circuit, the patient circuit broke and thus causing a leakage.There was no patient harm.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that during anesthesia procedure after having pulled the circuit, it fell apart.The part was scrapped.The damaged part could be verified in a received image.The device logs were not provided and the reported issue can therefore not be confirmed.Based on the received images, this failure will lead to leakage and stop of ventilation.The true cause of why the circuit broke has not been determined.H3 other text : 4114.

Event Description

Manufacturer's reference number: (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: 17132999
• MDR Text Key: 317214909
• Report Number: 8010042-2023-01127
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1