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

Model Number FLOW-C

Device Problem Output Problem (3005)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was a leakage in the anesthesia system and pressure too high.Unknown if a patient was involved.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

Investigation of the reported event has been completed.The anesthesia workstation was investigated onsite by the field service engineer and according to the information provided by the technician, the issue has not been recreated and no parts have been replaced.Evaluation of logs confirms reported auto ventilation leakage test failure.The initially reported "pressure to high" was found to be the message given in connection to the failing auto ventilation leakage test during system checkout.The full message is "pressure to high during measurement stage".The root cause to the reported issue has not been determined.

Event Description

Manufacturer's ref.#: (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: 10313735
• MDR Text Key: 200044826
• Report Number: 8010042-2020-00472
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• 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?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1