MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-25 for CYLINDER VALVE manufactured by Ceodeux, Inc., Ultrapure Equipment Technology S.a..
[20158377]
A respiratory therapist was exchanging an outpatient's "e" oxygen cylinder for a refilled cylinder. As the therapist was turning the valve stem to open the cylinder, the oxygen valve stem suddenly popped out hitting the ceiling at a high velocity missing the therapist. The oxygen valve had identifying marks of ceodeux. Dates of use: 2009. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010104 |
| MDR Report Key | 1327337 |
| Date Received | 2009-02-25 |
| Date of Report | 2009-02-25 |
| Date of Event | 2009-02-17 |
| Date Added to Maude | 2009-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYLINDER VALVE |
| Generic Name | POST TYPE CYLINDER VALVE FOR OXYGEN |
| Product Code | ECX |
| Date Received | 2009-02-25 |
| Returned To Mfg | 2009-02-18 |
| Device Expiration Date | 1998-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEODEUX, INC., ULTRAPURE EQUIPMENT TECHNOLOGY S.A. |
| Manufacturer Address | LINTGEN LU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2009-02-25 |