MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-28 for SMARTMONITOR 2 * manufactured by Respironic.
[18374080]
My daughter used the smartmonitor 2. The alarm did not sound and the child died. This was the third they gave me, the other two did not sound. There were used 3 smartmonitor in 2 months and the three failed. Dates of use: 3 days, 2006. Diagnosis: stop breathing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011241 |
| MDR Report Key | 1396183 |
| Date Received | 2009-05-28 |
| Date of Report | 2009-05-28 |
| Date of Event | 2006-07-07 |
| Date Added to Maude | 2009-06-02 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | SMARTMONITOR 2 |
| Generic Name | NONE |
| Product Code | NPF |
| Date Received | 2009-05-28 |
| Model Number | SMARTMONITOR 2 |
| Catalog Number | * |
| Lot Number | 300005285 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONIC |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2009-05-28 |