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

Model Number FLOW-I C40

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the anesthesia workstation did not deliver the set volume.No patient harm reported.(b)(4).

Event Description

Manufacturer´s ref #: (b)(4).

Manufacturer Narrative

The company field service engineer investigated the anesthesia workstation at the hospital.The investigation found indications of moisture/condensed water in the patient tubings that may have contributed to the problems with delivering the set volume.No logs or additional information have been received and the reported issue can therefore not be confirmed.We have not been able to determine the true case of the reported issue but according to the received information, moisture/condensation of water in the patient tubings may have contributed to the reported issue.

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 11337515
• MDR Text Key: 232175671
• Report Number: 8010042-2021-00400
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K191027
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C40
• Device Catalogue Number: 6677400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1