MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-19 for O2 TANK E CYLINDER * manufactured by Linde Gas North America.
[21832365]
A new and full o2 tank was put onto the transport cart and turned on after removing the red tab. In approximately 5 minutes, the tank was empty. A new tank was obtained and used without ill effects to the patient. The patient's oxygen was set at 12 liter per nc and that should have lasted 56 minutes on the new tank. ======================manufacturer response for o2 tank e cylinder, (brand not provided) (per site reporter). ======================i have talked to customer service at linde. I asked him these questions: 1. How do you think something like this could happen? 2. Has this been happening at other organizations? 3. Do you know how this could be prevented from happening again? He could not answer them. He said he would let the plant manager know and that he would be contacting me. Approximately one week later, i sent the same questions to the plant manager along with a request telling him to pick up the o2 tank and that i needed a follow up investigation letter sent to me once the tank was checked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4286062 |
| MDR Report Key | 4286062 |
| Date Received | 2014-11-19 |
| Date of Report | 2014-11-19 |
| Date of Event | 2014-11-12 |
| Report Date | 2014-11-19 |
| Date Reported to FDA | 2014-11-19 |
| Date Reported to Mfgr | 2014-12-01 |
| Date Added to Maude | 2014-12-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | O2 TANK E CYLINDER |
| Generic Name | CYLINDER, COMPRESSED GAS, AND VALVE |
| Product Code | ECX |
| Date Received | 2014-11-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 287E401 |
| ID Number | * |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINDE GAS NORTH AMERICA |
| Manufacturer Address | 575 MOUNTAIN AVE. MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-19 |