MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-26 for SMARTMONITOR 2 APNEA MONITOR * manufactured by Philips Respironics.
[1710183]
Child in infant seat turned blue and the apnea monitor did not alarm. Witnessed by parent, child was removed from seat and color improved and child was breathing with normal respirations. The monitor was running on battery power at the time. Home health respiratory therapist came to the home after the incident was reported and checked the machine and it appeared to be working. It was removed from the home and replaced with another machine. It has been sent to our clinical engineering department for evaluation. ====================== health professional's impression======================unsure, respiratory therapist was called to the home after the event and the monitor appeared to be working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1834106 |
| MDR Report Key | 1834106 |
| Date Received | 2010-08-26 |
| Date of Report | 2010-08-26 |
| Date of Event | 2010-08-23 |
| Report Date | 2010-08-26 |
| Date Reported to FDA | 2010-08-26 |
| Date Added to Maude | 2010-09-14 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | SMARTMONITOR 2 APNEA MONITOR |
| Generic Name | MONITOR, BREATHING FREQUENCY |
| Product Code | BZQ |
| Date Received | 2010-08-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-26 |