MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-14 for LINDE INTEGRATED VALVE (LIV) manufactured by Rotarex / Ceodeux.
[100433448]
This is a non-serious spontaneous adverse event report received from a maintenance coordinator in (b)(6) on (b)(6) 2018. This report concerns a male physician of unknown age. On (b)(6) 2018 he, and his co-workers, started handling an oxygen cylinder (serial number: (b)(4), batch number: brbhaa7php) which had not been in use. When the medical personnel started using it, they noticed a leaking noise. They put the cylinder back on the floor. The noise increased and then the valve (a linde integrated valve - liv ) separated from the cylinder. The cylinder escaped, hit a doctor's leg, went into a hallway and bounced off until the gas ran out. The doctor had a cut in his leg. Suturing was required. There was no hospitalization, only emergency care. The cylinder and the valve will be collected in the next few days and sent to jundiai site for investigation. At the time of this report the outcome was unknown. Additional information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003499947-2018-00001 |
| MDR Report Key | 7271462 |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-09 |
| Date of Event | 2018-01-10 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-02-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LINDE INTEGRATED VALVE (LIV) |
| Generic Name | INTEGRATED VALVE |
| Product Code | ECX |
| Date Received | 2018-02-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROTAREX / CEODEUX |
| Manufacturer Address | LU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-14 |