MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-15 for EASYPULSE 1800 SERIES * manufactured by Precision Medical.
[300193]
Pt's spouse turned on oxygen-conserving regulator on a portable cylinder and the regulator exploded, causing a metal cap from the regulator to hit them in the abdomen and knocked the air out of them spouse fell to the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028994 |
| MDR Report Key | 472490 |
| Date Received | 2003-07-15 |
| Date of Report | 2003-07-15 |
| Date of Event | 2003-07-05 |
| Date Added to Maude | 2003-07-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYPULSE |
| Generic Name | OXYGEN-CONSERVING REGULATOR |
| Product Code | NFB |
| Date Received | 2003-07-15 |
| Returned To Mfg | 2003-07-14 |
| Model Number | 1800 SERIES |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 461343 |
| Manufacturer | PRECISION MEDICAL |
| Manufacturer Address | 300 HELD DR N. HAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-15 |