MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-10-02 for PULSAIR OMS 50 manufactured by Devilbiss Health Care, Inc. Pulsair Plant.
[20685220]
Pt using oxygen conserving device with oxygen cylinder. Upon getting out of the car, heard a loud leaking noise, then saw some some, and flames coming from bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1052224-1996-00001 |
| MDR Report Key | 40946 |
| Report Source | 05 |
| Date Received | 1996-10-02 |
| Date of Report | 1996-09-26 |
| Date of Event | 1996-08-23 |
| Device Manufacturer Date | 1995-09-01 |
| Date Added to Maude | 1996-10-08 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULSAIR OMS 50 |
| Generic Name | * |
| Product Code | CCN |
| Date Received | 1996-10-02 |
| Model Number | OMS 50 |
| Catalog Number | OMS 50 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 42034 |
| Manufacturer | DEVILBISS HEALTH CARE, INC. PULSAIR PLANT |
| Manufacturer Address | 4106 AVENUE D FT PIERCE FL 34947 US |
| Baseline Brand Name | PULSAIR OMS 50 |
| Baseline Generic Name | PULSE FLOW DEMAND OXYGEN |
| Baseline Model No | OMS 50 |
| Baseline Catalog No | OMS 50 |
| Baseline ID | NA |
| Baseline Device Family | PULSE FLOW DEMAND OXYGEN CONTROL |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K813075 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-10-02 |