MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I C30; GAS-MACHINE, ANESTHESIA

Model Number	6677300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anesthesia system failed the pressure transducer test during system checkout.There was no patient involvement.Manufacturer's reference #: (b)(4).
Event or Problem Description
Manufacturer's reference #: (b)(4).
Additional Manufacturer Narrative
Investigation of this complaint has been completed.The field service engineer (fse) was on site, and the anesthesia system was investigated.The investigation concluded that both expiratory and reflector gas pressure transducers pcb's were faulty and needed to be replaced.Additionally, a faulty pcb expiratory channel was identified and replaced.The replaced parts were not available and can therefore not be investigated.After the replacement, the anesthesia system was successfully tested and cleared for clinical use.The evaluation of the received device logs confirms the reported problem.The test log shows that the pressure transducer failed due to the measured zero pressure offset for the expiratory and reflector pressure transducers pcb's being out of range.The pressure transducer pcb has a factory calibrated zero pressure offset value that normally is 2 ± 0.5 v.During system checkout, the zero pressure offset is measured and if the measured offset is outside the allowed limit (±300 mv from factory calibrated value) the test will fail.A faulty pressure transducer pcb may lead to inaccuracy in pressure measurement.This will be detected during system checkout and high priority alarms will be generated if the failure occurs during treatment.Our conclusion, based on the fse investigation and evaluation of the logs, is that the reported failure was caused by the expiratory and reflector pressure transducers pcb's.

• Brand Name: FLOW-I C30
• 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: 19770356
• Report Number: 8010042-2024-01163
• Device Sequence Number: 21062887
• Product Code: BSZ
• UDI-Device Identifier: 07325710001363
• UDI-Public: (01)07325710001363(11)161007
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/18/2024

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: 6677300
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown