MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-05-05 for PRECISION MEDICAL EASY PULSE 188705 manufactured by Precision Medical, Inc..
[15491768]
Pt was sitting in church using a easy pulse conserver for supplemental oxygen. The conserver came apart causing a injury to the pt. The pt was treated and released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2003-00001 |
| MDR Report Key | 458136 |
| Report Source | 08 |
| Date Received | 2003-05-05 |
| Date of Report | 2003-05-02 |
| Date of Event | 2003-04-27 |
| Date Mfgr Received | 2003-04-29 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2003-05-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JAMES PARKER |
| 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 | PRECISION MEDICAL EASY PULSE |
| Generic Name | OXYGEN CONSERVER |
| Product Code | NFB |
| Date Received | 2003-05-05 |
| Model Number | 188705 |
| Catalog Number | 188705 |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 447115 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DRIVE NORTHAMPTON PA 18067 US |
| Baseline Brand Name | EASY PULSE CONSERVER |
| Baseline Generic Name | CONSERVER |
| Baseline Model No | 188705 |
| Baseline Catalog No | 188705 |
| Baseline Device Family | CONSERVER |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K001412 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-05-05 |