MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ERGOSTAR CM50; BREATHING HOSE, DISPOSABLE

Catalog Number MP01850

Device Problems Crack (1135); Material Fragmentation (1261); Improper Chemical Reaction (2952)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Results will be provided in a separate follow-up-report.H3 other text : on-going.

Event Description

It was reported that the ergostar broke into pieces during use.One piece entered the patient's ariway but could be removed.No specific clinical signs or symptoms were reported.According to the user facility report, the customer believes that the event resulted from material fatique.

Manufacturer Narrative

The affected complaint material was available for examination.The reported defect could be confirmed, the patient-side connector was broken into 7 fragments.Further analysis of the available information revealed that a lubricant was used for the bronchoscopy.It is known that certain lubricants, such as mct oil, can pre-damage the plastic and lead to cracking.A product capa has already been opened and in the meantime the instructions for use have been updated with an advice that such lubricants must not be used.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the ergostar broke into pieces during use.One piece entered the patient's ariway but could be removed.No specific clinical signs or symptoms were reported.According to the user facility report, the customer beleives that the event resulted from material fatique.

• Brand Name: ERGOSTAR CM50
• Type of Device: 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: 17796547
• MDR Text Key: 324006938
• Report Number: 9611500-2023-00330
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MP01850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 11/08/2023
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention