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

Model Number	FLOW-I C30
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed the pressure transducer test, the flow transducer test and the leakage test during system check out.There was no patient involvement.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On-site investigation was performed by our field service engineer.The claimed issue was reproduced during troubleshooting.According to received service report, replacement of the patient cassette solved the issue.The ventilator passed all functional and safety tests and was cleared for clinical use.The patient cassette connects the fresh gas inlet and the volume reflector to the patient inspiratory/expiratory tubing.It consists of inspiratory/expiratory one-way valves, apl/peep valve and an expiratory flow transducer.The malfunction of mentioned part will not affect ventilation.This part is only for measuring purposes.The root cause to the reported issue has not been determined.The correction of field #h4 device manufacture date was required.This is based on the internal evaluation.#h4 manufacture date: previous manufacture date: 02/18/2022; corrected manufacture date: 01/31/2022.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• Brand Name: FLOW-I
• 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: 16910105
• Report Number: 8010042-2023-00911
• Device Sequence Number: 7206167
• Product Code: BSZ
• UDI-Device Identifier: 07325710001363
• UDI-Public: (01)07325710001363(11)220131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/11/2023

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-I C30
• Device Catalogue Number: 6677300
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown