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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2022

Event Type  malfunction  

Event Description

It was reported that the anesthesia system failed the pressure transducer test and the afgo (additional fresh gas outlet) test during system check out.There was no patient involvement.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The anesthesia system was investigated at the hospital by the distributor field service engineer.The n2o gas module was found faulty and was replaced.The device logs were downloaded and sent for evaluation.The replaced n2o gas module has not been returned.The reported flow transducer test failure could be confirmed in the received logs.The generated error code indicates a faulty n2o gas module.Based on the information stating that the replacement of the n2o gas module solved the reported issue, our conclusion is that a faulty n2o gas module caused flow transducer test failure.The root-cause has not been determined since the replaced part has not been available for investigation.In addition to the flow transducer test failure, several other sub tests such as pressure transducer test, safety valve test, afgo valve test (additional fresh gas outlet), had failed on different occasions, but without additional information, the true cause of these failure has not been determined.

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: 15208314
• MDR Text Key: 303040377
• Report Number: 8010042-2022-01374
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: WA
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

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: 08/08/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose