MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-28 for CPAP CPAP OS manufactured by Emergent Respiratory Products, Llc.
[3632723]
Ems responders identified pt with shortness of breath, possible due to copd/pneumonia. Pt reportedly appeared by her distress level to benefit from cpap. Cpap failed to hold pressure. Pt was transported to emergency department, respiratory distress and hypotension identified and pt admitted to intensive care unit for f/u care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030766 |
| MDR Report Key | 3209251 |
| Date Received | 2013-06-28 |
| Date of Report | 2013-06-28 |
| Date of Event | 2013-06-24 |
| Date Added to Maude | 2013-07-09 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPAP |
| Generic Name | CPAP |
| Product Code | NHJ |
| Date Received | 2013-06-28 |
| Model Number | CPAP OS |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMERGENT RESPIRATORY PRODUCTS, LLC |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-28 |