MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ERGOSTAR CM55; BREATHING FILTER

Model Number	MP01855
Medical Device Problem Codes	Fracture (1260); Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was induced for a surgical procedure in the induction department without any special incidents.A perseus was used as the anesthesia machine and a reusable tube system with filter, tube extension and mask was also used.After intubation, the patient was switched from manual ventilation to pc.The user noticed that there was a leak, which was getting bigger by the minute.The customer suspected that the tube was the cause of the leak and reintubated the patient.After reintubation, the patient was transferred from the induction to the room and continued to be ventilated on a perseus in pc.The user reported that the leakage detected in the induction was also present with the new tube.After a short time, an audible noise could be heard, which was due to a crack in the ergostar cm 55.Ergostar was replaced and ventilation was continued without further incidents.
Additional Manufacturer Narrative
The investigation is still on going.The results will be provided with a follow-up report.
Additional Manufacturer Narrative
The ergostar cm 55 in question was available for investigation.The described error pattern was confirmed during the visual inspection.The ergostar hose has a tear at the transition to the patient-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.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 a patient was induced for a surgical procedure in the induction department without any special incidents.A perseus was used as the anesthesia machine and a reusable tube system with filter, tube extension and mask was also used.After intubation, the patient was switched from manual ventilation to pc.The user noticed that there was a leak, which was getting bigger by the minute.The customer suspected that the tube was the cause of the leak and reintubated the patient.After reintubation, the patient was transferred from the induction to the room and continued to be ventilated on a perseus in pc.The user reported that the leakage detected in the induction was also present with the new tube.After a short time, an audible noise could be heard, which was due to a crack in the ergostar cm 55.Ergostar was replaced and ventilation was continued without further incidents.

• Brand Name: ERGOSTAR CM55
• Common Device Name: BREATHING FILTER
• 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: 22185408
• Report Number: 9611500-2025-00297
• Device Sequence Number: 8356195
• Product Code: BSZ
• UDI-Device Identifier: 04048675420705
• UDI-Public: (01)04048675420705
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/07/2025

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: MP01855
• Device Lot Number: LOT 6508.2503.15
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown