MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-26 for CAS INFANT APNEA MONITOR manufactured by Cas Medical Systems, Inc..
[1851926]
The monitor did not alarm for an apnea event, however, the indicator light for apnea was on. Dates of use: (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020423 |
| MDR Report Key | 2074970 |
| Date Received | 2011-04-26 |
| Date of Report | 2011-04-26 |
| Date of Event | 2011-03-11 |
| Date Added to Maude | 2011-05-06 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAS INFANT APNEA MONITOR |
| Generic Name | AMI APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2011-04-26 |
| Returned To Mfg | 2011-04-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-04-26 |