MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ERGOSTAR CM 40; CONNECTOR, AIRWAY (EXTENSION)

Model Number	MP01840
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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 that shortly after installation, the ergostar split at the boundary between the flexible and rigid parts of the corrugated tube.The system was replaced.No injury reported.
Additional Manufacturer Narrative
The ergostar cm 40 in question was available for investigation.The described error pattern was confirmed during the visual inspection.The ergostar is torn between the first 4 turns of the spiral at the transition to the device-side connector.It was determined that during the manufacture of the raw hoses, the setting of the guide roller resulted in a thin hose wall, which promoted the formation of tears.The supplier has already corrected the guide roller setting and provided additional training to staff so that they can recognize and avoid this fault in future.The affected material was produced before the measures were implemented.During production, the circuits are 100% checked for leaks before packaging and shipping.If the crack in the tube material causes a significant leak, this is detected during the self-test or during operation and an alarm is triggered.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.
Event or Problem Description
It was reported that shortly after installation, the ergostar split at the boundary between the flexible and rigid parts of the corrugated tube.The system was replaced.No injury reported.

• Brand Name: ERGOSTAR CM 40
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• 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: 22466924
• Report Number: 9611500-2025-00367
• Device Sequence Number: 14477327
• Product Code: BZA
• UDI-Device Identifier: 04048675420736
• UDI-Public: (01)04048675420736
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: MP01840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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