MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-08 for AMIPLUS manufactured by Cas Medical.
[2545457]
Per the family the alarms are not audibly sounding; the download via the apnea program shows that there have been alarms. The monitor alarms when it starts up and does the self check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024609 |
| MDR Report Key | 2492884 |
| Date Received | 2012-03-08 |
| Date of Report | 2012-03-08 |
| Date of Event | 2012-03-06 |
| Date Added to Maude | 2012-03-16 |
| 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 |
| 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 | AMIPLUS |
| Generic Name | APNEA MONITOR |
| Product Code | BZQ |
| Date Received | 2012-03-08 |
| Model Number | AMIPLUS |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAS MEDICAL |
| Manufacturer Address | 44 E INDUSTRIAL BLVD. BRANDFORD CT 06405 US 06405 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2012-03-08 |