MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for DALCON ALERT manufactured by Amplion Clinical Communications.
[95667877]
Support analyst spoke with the site who reported a patient coded at 17:32 hours the night before. They alleged they had an issue with a vent alert message not going to one of the nurses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009164985-2017-00001 |
| MDR Report Key | 7100279 |
| Date Received | 2017-12-08 |
| Date of Report | 2017-12-07 |
| Date of Event | 2014-10-16 |
| Date Mfgr Received | 2014-10-16 |
| Device Manufacturer Date | 2012-12-03 |
| Date Added to Maude | 2017-12-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR FRANK GRANT |
| Manufacturer Street | 632 MELROSE AVE |
| Manufacturer City | NASHVILLE TN 37211 |
| Manufacturer Country | US |
| Manufacturer Postal | 37211 |
| Manufacturer Phone | 6155779000 |
| Manufacturer G1 | AMPLION CLINICAL COMMUNICATIONS |
| Manufacturer Street | 632 MELROSE AVE |
| Manufacturer City | NASHVILLE TN 37211 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DALCON ALERT |
| Generic Name | DALCON ALERT;REMOTE ALERT MONITORING |
| Product Code | ILQ |
| Date Received | 2017-12-08 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMPLION CLINICAL COMMUNICATIONS |
| Manufacturer Address | 632 MELROSE AVE NASHVILLE TN 37211 US 37211 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-12-08 |