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

Model Number	FLOW-E
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia workstation failed the o2 flush test and the afgo (additional fresh gas outlet) test during the system checkout.There was no patient involvement.Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
Based on the information collected to date, the provided problem description and the inspection of the device conducted by the technician, it has been clarified that the initially claimed o2 flush test failure and afgo valve test failure, has not been reproduced during on-site investigation according to information provided in the complaint.The technician performed troubleshooting and could not reproduce the issues.No parts have been replaced.Nevertheless, the issue can be confirmed in provided device's logs.The device failed to meet its specifications.It has not been used at the time of the event.There has been no adverse event sustained as a result of the issue.The afgo is controlled by a valve that can be switched to supply fresh gas either to the afgo connector or to the patient cassette.The o2 flush valve (a push-button) is used to manually supply the fresh gas with an additional o2 gas supply.The root cause to the reported issue has not been determined.The correction of field #h8 usage of device and #h4 manufacture date were required.This is based on the internal evaluation.#h8 usage of device: previous usage of device: unknown.Corrected usage of device: reuse.#h4 manufacture date: previous manufacture date: 04/01/2020.Corrected manufacture date: 03/04/2020.
Event or Problem Description
Manufacturer's reference #: (b)(4).

• Brand Name: FLOW-E
• 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: 15898123
• Report Number: 8010042-2022-02135
• Device Sequence Number: 12037218
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)200304
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: FLOW-E
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown