MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-14 for EMERGENT RESPIRATORY PRODUCTS * manufactured by Emergent Respiratory Products, Inc..
[590001]
A male c/o shortnes of breath with wheezing noted. Vitals assessed, pulse ox 78%, o2 non rebreather @15lpm, blood glucose assessed @246, iv started, ekg assessed, pt moved to ambulance with continued treatment per protocol. Cpap applied enroute to hospital with success and change in saturation noted 5-8 mins into the 15 minute transport, the oxygen flow stopped from the cpap system. O2 tank was confirmed over 500 lbs, mask/tubing set changed with no change. No leakage of oxygen noted by paramedic. Pt arrived hospital in respiratory arrest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041967 |
| MDR Report Key | 819711 |
| Date Received | 2007-02-14 |
| Date of Report | 2007-02-14 |
| Date of Event | 2007-02-02 |
| Date Added to Maude | 2007-02-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMERGENT RESPIRATORY PRODUCTS |
| Generic Name | CPAP-0S |
| Product Code | NHJ |
| Date Received | 2007-02-14 |
| Returned To Mfg | 2007-02-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 807194 |
| Manufacturer | EMERGENT RESPIRATORY PRODUCTS, INC. |
| Manufacturer Address | 420 EXCHANGE STE 250 IRVINE CA 92602 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-02-14 |