MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-01-30 for EASY PULSE CONSERVER * manufactured by Precision Medical, Inc..
[16796531]
Oxygen tank was leaking, patient called the supplier for service. Supplier came and serviced tanks. Left the patient's home without securing the tanks after the service call. One of the tanks fell over causing a fire that burned the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2006-00001 |
| MDR Report Key | 670180 |
| Report Source | 07 |
| Date Received | 2006-01-30 |
| Date of Report | 2006-01-30 |
| Date of Event | 2005-04-13 |
| Date Mfgr Received | 2006-01-18 |
| Date Added to Maude | 2006-02-02 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JIM PARKER, MANAGER |
| Manufacturer Street | 300 HELD DRIVE |
| Manufacturer City | NORTHAMPTON PA 18067 |
| Manufacturer Country | US |
| Manufacturer Postal | 18067 |
| Manufacturer Phone | 6102626090 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASY PULSE CONSERVER |
| Generic Name | OXYGEN REGULATING CONSERVER |
| Product Code | NFB |
| Date Received | 2006-01-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 659494 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. NORTHAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-01-30 |