MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VENTSTAR HOSES OXYLOG 3000; BREATHING HOSE, DISPOSABLE

Catalog Number 5702871

Device Problems Fracture (1260); Insufficient Information (3190)

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

Event Date 10/16/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that the swivel connector (proximal) of the breathing hose was broken.The inner connector part reportedly was crumbled during patient transport.The situation was noticed by the doctor and there were some diffuculties to oxynate the patient.No patient injury reported.

Event Description

It was reported that the swivel connector (proximal) of the breathing hose was broken.The inner connector part reportedly was crumbled during patient transport.The situation was noticed by the doctor and there were some difficulties to oxynate the patient.No patient injury reported.

Manufacturer Narrative

The affected breathing circuit of type ventstar oxylog was already discarded by the customer so that a case-specific investigation could not be performed.In general the material of the swivel elbow made from styrene butadiene copolymer can be weakened by mct oil or by the use of disinfection agents.Reportedly no mct oil was used.As the breathing circuit is a disposable product the use of disinfection agents is not allowed.Finally, the root cause for the reported symptom could not be determined due to insufficient information.A broken swivel connector is obvious for the user.A resulting relevant leakage is detected and alarmed by the connected oxylog device.In the last 12 months no similar case has been reported so that the current complaint was assessed as single event.H3 other text : the affected breathing circuit was not available for investigation.

• Brand Name: VENTSTAR HOSES OXYLOG 3000
• 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
• MDR Report Key: 16100994
• MDR Text Key: 307666325
• Report Number: 9611500-2023-00004
• Device Sequence Number: 1
• Product Code: CAI
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5702871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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