MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ANESTHESIA CIRCUIT KIT FLEX 6; ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE

Model Number	MP02744
Medical Device Problem Codes	Material Disintegration (1177); Fracture (1260); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported the breathing circuit broke at the flex point straight through the tubing.No injury reported.
Additional Manufacturer Narrative
The described error pattern could be confirmed based on the available information and based on the investigation of returned material from similar complaints.It was found that a crack in the flexible hose most likely caused by a mechanical force was the root cause.An internal test of the pull-off forces with sample parts revealed no deviations and all parts conformed to standards and specifications with regard to the pull-off forces.Functional tests were performed and it could be confirmed that the usage of certain hose holders or hose holder plates with a flat design can cause such cracks.It was confirmed that hose holders with a larger contact surface do not press into the individual folds as the flatter ones do, avoiding unfavorable application of force.Leakages due to cracks will be detected during the leakage test of the main device prior to use.In case such cracks form during use, leakage will occur.Depending on the size of the leakage and the selected ventilation pressure, the ventilator / anaesthesia device can compensate for this.If the leakage cannot be compensated, ventilators according to iso 80601-2-12 and anaesthesia devices according to iso 60601-2-13 will generate visual and audible alarms according to the set alarm limits.The detection of cracks is improved if the leakage test is only carried out after the extendable hose has been stretched to the required length.This is also described in the instructions for use.Nevertheless, the risk assessment performed determined an increased risk.In order to inform all customers of potentially affected breathing circuits about the unacceptable risk resulting from the situation, a field safety notice will be published in the course of a field safety corrective action in february 2025.
Event or Problem Description
It was reported the breathing circuit broke at the flex point straight through the tubing.No injury reported.

• Brand Name: ANESTHESIA CIRCUIT KIT FLEX 6
• Common Device Name: ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20910941
• Report Number: 9611500-2024-00563
• Device Sequence Number: 8453971
• Product Code: OFP
• UDI-Device Identifier: 04048675412137
• UDI-Public: (01)04048675412137
• Combination Product (Y/N): N
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: MP02744
• Device Lot Number: 6803.2405.14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown