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

Model Number	6887900
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The anesthesia system failed the pressure transducer test during system checkout.There was no patient involvement.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that the flow-e - failed the safety valve test & pressure transducer test.The reflector pressure transducer had a zero pressure offset measured at 9,998 volt.A normal zero pressure offset is 2 volt.According to received information, the reflector pressure transducer was replaced with another new one and this solved the issue.The system was successfully tested and was cleared for clinical use.The replaced part has not been returned for investigation and there are no device logs from this flow-e.We have not been able to determine the true cause of the reported issue.A correction of field # d1 brand name, # d4 version and model #, d4 unique identifier (udi) # and h4 manufacturer date were done.D1 ¿ brand name - previous brand name: flow-i, corrected brand name: flow-e anesthesia system.D4 ¿ version or model # - previous version or model #: flow-i c20, corrected version or model #: 6887900.D4 unique identifier (udi) # was updated to (b)(6).H4 manufacturer date: corrected to 08/24/2023.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-E ANESTHESIA SYSTEM
• Common Device Name: 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: 18775915
• Report Number: 8010042-2024-00359
• Device Sequence Number: 12804409
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)230824
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: 6887900
• Device Catalogue Number: 6887900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown