MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for OXYGEN E-CYLINDER 7782-44-7 manufactured by Linde Gas North America Llc Lifegas.
[70784815]
Patient Sequence No: 1, Text Type: N, H10
[70784816]
The plastic cap was removed from the regulator on a new/full e-cylinder psi read 2000. After 15 minutes on flow rate of 15 liter per minutes (l/m) the reservoir bag became flat. The regulator now read empty. Patient ventilated by bag and placed on wall o2; no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6431421 |
| MDR Report Key | 6431421 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-17 |
| Date of Event | 2016-04-27 |
| Report Date | 2017-03-17 |
| Date Reported to FDA | 2017-03-17 |
| Date Reported to Mfgr | 2017-03-17 |
| Date Added to Maude | 2017-03-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN E-CYLINDER |
| Generic Name | CYLINDER, COMPRESSED GAS, AND VALVE |
| Product Code | ECX |
| Date Received | 2017-03-24 |
| Catalog Number | 7782-44-7 |
| Lot Number | 084H607 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINDE GAS NORTH AMERICA LLC LIFEGAS |
| Manufacturer Address | 2045 E AURORA RD. TWINSBURG OH 44087 US 44087 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-24 |