MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-26 for SMART MONITOR * manufactured by Respironics, Inc..
[1152510]
While the mother of the infant was feeding the baby, the apnea monitor respiration light stopped blinking and the heart rate light started to slow. The baby stopped breathing. The baby's family performed cpr and the baby was transported to the hospital for observation. The patient's family noted the heart rate was greater than 200 bpm, but noted the monitor did not alarm. However, the high heart rate indicator light was showing red; indicating that an alarm had occurred. The alarm settings were hhr=200, lhr=80, apnea delay= 20 seconds. The monitor was removed from the home and sent to the manufacturer for testing. Initial response has been no problems identified with the monitor; facility is currently awaiting written report. They could see two events, and according to the read out, the alarm sounded both times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1472619 |
| MDR Report Key | 1472619 |
| Date Received | 2009-08-26 |
| Date of Report | 2009-08-26 |
| Date of Event | 2009-08-06 |
| Report Date | 2009-08-26 |
| Date Reported to FDA | 2009-08-26 |
| Date Added to Maude | 2009-09-15 |
| 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 |
| 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 | SMART MONITOR |
| Generic Name | APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2009-08-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-26 |