MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VENTSTAR FLEX 220; BREATHING HOSE , DISPOSABLE

Model Number	MP00355
Medical Device Problem Codes	Fracture (1260); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the circuit was cut while it was placed in the circuit holder.No injury reported.
Additional Manufacturer Narrative
The investigation was just started.The result will be forwarded once the investigation is closed.
Event or Problem Description
It was reported that during surgery, the circuit was cut while it was placed in the circuit holder.No injury reported.
Additional Manufacturer Narrative
For the investigation the provided photo was analysed.A crack in the flexible hose was identified and the reported symptom could be confirmed.The error pattern was evaluated and mechanical force in combination with a sharp edge was identified to be the most likely root cause for the found cracks.In this case it was reported that the hose cracked when placing it into the hose holder.This is the first case which was reported in connection with a hose holder.In case of a relevant leakage, the connected main device will post a corresponding alarm during the pre-use check.During use, the leakage will either be compensated or alarmed accordingly.The number of similar cases, related to the same symptom, 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.

• Brand Name: VENTSTAR FLEX 220
• Common Device Name: BREATHING HOSE , 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: 20095100
• Report Number: 9611500-2024-00361
• Device Sequence Number: 8475239
• Product Code: BZO
• UDI-Device Identifier: 04048675422037
• UDI-Public: (01)04048675422037
• 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,Followup
• Report Date (Section B): 10/09/2024

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: MP00355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown