MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-22 for PRECISION MEDICAL 1600M * manufactured by Precision Medical Inc..
[372290]
Ekg tech was checking o2 cylinders for replacement, she was checking a cylinder for e. R. When she turned the main valve on, the flow meter exploded from the pressure release & debris was scattered hitting the tech in the face and hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034981 |
| MDR Report Key | 585386 |
| Date Received | 2005-03-22 |
| Date of Report | 2005-03-22 |
| Date of Event | 2005-03-22 |
| Date Added to Maude | 2005-03-29 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISION MEDICAL |
| Generic Name | REGULATOR/FLOW METER COMBINATION |
| Product Code | CCN |
| Date Received | 2005-03-22 |
| Model Number | 1600M |
| Catalog Number | * |
| Lot Number | 0800 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 575218 |
| Manufacturer | PRECISION MEDICAL INC. |
| Manufacturer Address | 300 HELD DR NORTH HAMPTON PA 18067 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-22 |