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 No Patient Involvement (2645)

Event Date 01/28/2021

Event Type  malfunction  

Event Description

It was reported that the anesthesia workstation failed the flow transducer test during system checkout.There was no patient involvement.Manufacturer's reference #:(b)(4).

Event Description

Manufacturer's reference #: (b)(4).

Manufacturer Narrative

Investigation of the reported event has been completed.Our technician investigated the system and the reported failure was reproduced.According to the information provided by the technician, the issue could be solved by replacing a damaged o2 gas hose.No further failures were reported.Device logs nor o2 gas hose have been available for the further analysis of the issue.The root cause of the reported issue has not been determined.

• 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: 11383851
• MDR Text Key: 233719585
• Report Number: 8010042-2021-00503
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/26/2021

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-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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