MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH BREATHING HOSE, DISPOSABLE (VENTSTAR COAX 180)

Lot Number 102780

Device Problems Leak/Splash (1354); Medical Gas Supply Problem (2985)

Patient Problem Toxicity (2333)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

It was reported that: due to a leakage between inner and outer hose of a coaxial breathing hose system which was connected to an intensive care ventilator, the inspired and expired gas were mixed.As a result the co2 content of the gas being supplied to the patient rose to toxic level.

Manufacturer Narrative

The affected breathing hose system is a so-called coax-system in which the inspiration hose is surrounded by the expiration hose.The first investigation showed that the inner hose was detached from a connector, resulting in an inner leakage.This situation has caused a mixing of inspiration gas with exhaled air.The investigation was started but is not yet concluded.The investigation result will be reported in the follow-up report.

• Brand Name: BREATHING HOSE, DISPOSABLE (VENTSTAR COAX 180)
• Type of Device: BREATHING HOSE, DISPOSABLE
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; moislinger allee 53/55; luebeck 2354 2; GM 23542
• Manufacturer Contact: frank clanzett ; moislinger allee 53-55; luebeck 23542 ; GM 23542 ; 18822868
• MDR Report Key: 4554064
• MDR Text Key: 5462147
• Report Number: 9611500-2015-00004
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 102780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/22/2015
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Other