MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-30 for EASY PULSE CONSERVER 188705 * manufactured by Precision Medical Inc..
[252146]
Easy pulse conserver was being placed on an oxygen tank after the yoke seal was changed. When the post valve was opened on the tank the conserver flew apart, hitting the hand of the attending home care tech; part of the conserver punctured a nearby wall. The pt receiving the oxygen was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523148-2002-00004 |
| MDR Report Key | 419228 |
| Report Source | 05 |
| Date Received | 2002-09-30 |
| Date of Report | 2002-09-25 |
| Date of Event | 2002-09-25 |
| Date Mfgr Received | 2002-09-25 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2002-10-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JAMES PARKER |
| Manufacturer Street | 300 HELD DR |
| 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 | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASY PULSE CONSERVER |
| Generic Name | OXYGEN CONSERVER |
| Product Code | NFB |
| Date Received | 2002-09-30 |
| Returned To Mfg | 2002-09-27 |
| Model Number | 188705 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 408273 |
| 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 | 2002-09-30 |