MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2003-12-16 for PRECISION MEDICAL EASY PULSE 188705 manufactured by Precision Medical, Inc..
[349828]
Pt brought conserver into home care facility, because the unit was not functioning, unit was leaking oxygen. Customer service representative turned on unit, the unit flew into pieces hitting the pt in the stomach and the customer service representative in the hand. Both people were taken to the emergency room for treatment, and released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2003-00004 |
| MDR Report Key | 504948 |
| Report Source | 08 |
| Date Received | 2003-12-16 |
| Date of Report | 2003-12-15 |
| Date of Event | 2003-11-20 |
| Date Mfgr Received | 2003-12-09 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2004-01-08 |
| 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 | 3 |
| 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 |
| Remedial Action | NO |
| 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 | 2003-12-16 |
| Returned To Mfg | 2003-12-09 |
| Model Number | 188705 |
| Catalog Number | 188705 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 493790 |
| Manufacturer | PRECISION MEDICAL, INC. |
| Manufacturer Address | 300 HELD DR. 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 | 2003-12-16 |