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	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed to ventilate while on patient.There was no patient harm.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the reported failure in this complaint has been completed.Our field service engineer (fse) investigated the anesthesia system at the hospital but was unable to duplicate the reported issues.The anesthesia system was successfully tested and cleared for clinical use.A complete set of device logs was received.Successful system checkout were performed prior to and between the cases on the event date.The received logs confirms that clinical alarms were generated but the true cause of these alarms has not been determined.The technical log has no recordings during this date which indicates the absence of technical malfunctions in the system.The received trend log doesn¿t cover the reported event/issues.We have not been able to establish the true cause of the reported event.
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: 19905326
• Report Number: 8010042-2024-01277
• Device Sequence Number: 21015557
• Product Code: BSZ
• UDI-Device Identifier: 07325710010457
• UDI-Public: (01)07325710010457(11)211014
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K191027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown