MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-01 for CAIRE PORTABLE * manufactured by Columbia Ancillary Services, Inc..
[935532]
Patient was using a portable oxygen tank with the o2 delivered via nasal cannula when "vapor" started coming out around the tubing. Patient suffered burns to neck, face and nose requiring medical treatment. Bacitracin to burns on face and silvadene to burns on neck. O2 tank filled by cna - not leaking, no vapor escaping, no freezing noted. Lpn turned tank on at 2 l via n/c. No leaking noted. Approximately 45 minutes later, resident provided ice cream by cna. No problems noted with o2 at that time. A few minutes later, cna found o2 tubing frozen, tank bubbling, frozen, and resident with burns on face and neck. O2 tank immediately removed and sent to maintenance department. Resident evaluated and treated overnight at hospital. In 2008, tank returned for inspection. Staff report that o2 secured on back of wheelchair in upright position. Dose or amount: 2 liters; frequency: continuous; route: nc. Dates of use: 2007 to present. Suspect stroller used 2080. Diagnosis or reason for use: copd. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008498 |
| MDR Report Key | 1183945 |
| Date Received | 2008-10-01 |
| Date of Report | 2008-09-24 |
| Date of Event | 2008-09-22 |
| Date Added to Maude | 2008-10-07 |
| 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 |
| 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 | CAIRE PORTABLE |
| Generic Name | OXYGEN STROLLER |
| Product Code | ECX |
| Date Received | 2008-10-01 |
| Returned To Mfg | 2008-09-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1220239 |
| Manufacturer | COLUMBIA ANCILLARY SERVICES, INC. |
| Manufacturer Address | 1388 STATE ROUTE 487 BLOOMSBURG PA 17815 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-01 |