MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-11-03 for OXYMATIC UNK manufactured by Chad Therapeutics, Inc..
[331529]
In 10/2003, chad received a letter from an organization informing the co that a client of theirs had been involved in an accident in 2003. Preliminary info provided by the organization indicated that the pt had just placed their conserver/regulator on a new oxygen cylinder and when turned on pt heard a leak. Before pt was able to close the oxygen valve, a fire ignited. In their attempt to push the cylinder outside, the cylinder fell to the ground and some furniture became involved in the fire. The cylinder came to rest near another oxygen cylinder. After being exposed to the flame from the first cylinder for some time, second cylinder exploded and considerable damage was done to the house. The oxygen cylinders were not supplied by chad therapeutics. The pt received burns to their hands from trying to push the cylinder outside after it had ignited but was outside when second cylinder burst. Pt was transported to a local hosp, received treatment for the burns and was released. A second person who was assisting pt spouse out of the house received some lacerations from debris when second cylinder burst. The second patient was also taken to the hosp for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024040-2003-00001 |
| MDR Report Key | 494820 |
| Report Source | 00 |
| Date Received | 2003-11-03 |
| Date Added to Maude | 2003-11-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | SHAHAN MOSES |
| Manufacturer Street | 21622 PLUMMER ST. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | * |
| Manufacturer G1 | CHAD THERAPEUTICS, INC. |
| Manufacturer Street | 21622 PLUMMER ST. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91311 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYMATIC |
| Generic Name | OXYGEN CONSERVING DEVICE |
| Product Code | NFB |
| Date Received | 2003-11-03 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 483535 |
| Manufacturer | CHAD THERAPEUTICS, INC. |
| Manufacturer Address | 21622 PLUMMER ST CHATSWORTH CA 91311 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-03 |