MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-14 for CONTINUOUS POSITIVE AIRWAY PRESSURE 1900-001 manufactured by Emergent Respiratory Products, Inc.
[16641745]
Call went out for trouble breathing. Per paramedic, he had difficulty with setting the cpap adjustment knob. He stated while moving the dial to increase the cm/h2o, it jumped into the #20cm/h2o range which caused the patient to have an even more difficult time with breathing, after some time he was able to set it to a more comfortable level for the patient which he stated was around 10cm/h2o. Problem: the knob adjustment did not work smoothly. Dates of use: one day in 2007 (20 minutes). Diagnosis: chf. Event abated after use: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002675 |
| MDR Report Key | 866858 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-06-14 |
| Date of Event | 2007-06-11 |
| Date Added to Maude | 2007-06-25 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINUOUS POSITIVE AIRWAY PRESSURE |
| Generic Name | CPAP |
| Product Code | NHJ |
| Date Received | 2007-06-14 |
| Returned To Mfg | 2007-06-15 |
| Model Number | 1900-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 850074 |
| Manufacturer | EMERGENT RESPIRATORY PRODUCTS, INC |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-14 |