MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-02-13 for BREATHING HOSE, DISPOSABLE (VENTSTAR COAX 180) manufactured by Draeger Medical Gmbh.
[5462147]
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.
Patient Sequence No: 1, Text Type: D, B5
[12963288]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611500-2015-00004 |
| MDR Report Key | 4554064 |
| Report Source | 06,07 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-02-13 |
| Date of Event | 2015-01-19 |
| Date Facility Aware | 2015-01-22 |
| Date Mfgr Received | 2015-01-22 |
| Date Added to Maude | 2015-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK CLANZETT |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | LUEBECK 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal | 23542 |
| Manufacturer Phone | 18822868 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHING HOSE, DISPOSABLE (VENTSTAR COAX 180) |
| Generic Name | BREATHING HOSE, DISPOSABLE |
| Product Code | BYE |
| Date Received | 2015-02-13 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 102780 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL GMBH |
| Manufacturer Address | MOISLINGER ALLEE 53/55 LUEBECK 23542 GM 23542 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-02-13 |