MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FILTER SAFESTAR 55 PLUS; FILTER , DISPOSABLE

Model Number	MP05790
Medical Device Problem Codes	Imprecision (1307); Decreased Sensitivity (2534)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation of the available information and other reported cases, it was found that the flow conditions in the housing of the affected filters were causing the flattened curve.Our analyses have shown that the comparatively slower increase in the co2-curve only occurs when the gas sample line is connected to the gas sampling port of a filter/hme shown in the attached list.Other setups are not affected.If a therapeutic decision is made solely on the basis of a slowly rising co2-curve, unnecessary medication might lead to a serious deterioration in the state of health of certain patient groups (e.G.With pre-existing cardiac conditions).Thus, a field safety corrective action (fsca) (manufacturer ref.: pr157728) was initiated 2025-05-20 to inform all users until beginning of june 2025 by means of a field safety notice and advise them to not make therapeutic decisions based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anesthesia machine used.The instructions for use of the referenced filters will also be updated to include this information.
Event or Problem Description
It was reported that the etco2-curve was displayed flattened.During further internal review, it was found that the event was to be assessed reportable because the changed curve could lead to misinterpretation by the user.

• Brand Name: FILTER SAFESTAR 55 PLUS
• Common Device Name: FILTER , DISPOSABLE
• 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: 22084501
• Report Number: 9611500-2025-00271
• Device Sequence Number: 12729410
• Product Code: BSZ
• UDI-Device Identifier: 04048675558736
• UDI-Public: (01)04048675558736
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/26/2025

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: MP05790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown