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

Model Number FLOW-C

Device Problems Break (1069); Output Problem (3005)

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

Event Date 08/13/2023

Event Type  malfunction  

Event Description

It was reported that the anesthesia workstation had an excessive leakage.There was no patient harm reported.Manufacturer's ref.(b)(4).

Manufacturer Narrative

On-site investigation was performed by our field service engineer.The field service engineer successfully changed the patient cassette and the anesthesia unit passed all functional and safety tests and was cleared for clinical use.The faulty patient cassette was then sent for further investigation.The patient cassette immediately fails the pressure transducer test in sco.An ocular inspection then reveals that the exp valve cover is faulty due to a broken plastic seal.The received logs show that there were issues with failing pressure transducer test in sco.The patient cassette is the main interface for distributing gas to and from the patient.The root cause for the reported issue could not be determined.

Event Description

Manufactures reference id: (b)(4).

• Brand Name: FLOW-C
• 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: 17659678
• MDR Text Key: 322528445
• Report Number: 8010042-2023-01686
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 07325710009765
• UDI-Public: (01)07325710009765(11)210909
• Combination Product (y/n): N
• Reporter Country Code: IZ
• 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: 08/31/2023

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
• Device Model Number: FLOW-C
• Device Catalogue Number: 6887700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1