MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-28 for OXYGEN E-CYLINDERS (5 CYLINDERS IN HOME) manufactured by The Aftermarket Group.
[138155662]
A fire occurred at patient? S home. Patient was home at the time of the fire. An oxygen concentrator and 5 oxygen e-cylinders were in the home. The fire department reported that neighbors heard some explosions prior to the fire being reported. The fire department found the patient deceased. The medical examiner reported the patient had smoke inhalation and post-mortem burns. An autopsy is pending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8400794 |
| MDR Report Key | 8400794 |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-28 |
| Date of Event | 2019-02-18 |
| Date Facility Aware | 2019-02-19 |
| Report Date | 2019-02-28 |
| Date Reported to FDA | 2019-02-28 |
| Date Reported to Mfgr | 2019-02-28 |
| Date Added to Maude | 2019-03-07 |
| 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 | 0 |
| 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 |
| Generic Name | OXYGEN E-CYLINDERS (5 CYLINDERS IN HOME) |
| Product Code | CAN |
| Date Received | 2019-02-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE AFTERMARKET GROUP |
| Manufacturer Address | 39400 TAYLOR PARKWAY NORTH RIDGEVILLE OH 44039 US 44039 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-02-28 |