MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-25 for VOALTE ONE VERSION 2.5.2 manufactured by Voalte, Inc..
[59161023]
On (b)(6) 2016, patient connected to telemetry monitor. At 09:02, patient found unresponsive. Telemetry monitor strips reviewed and it was noted that the patient had a ventricular fibrillation at 08:39 which did not produce an audible alarm on the voalte device carried by rn. Philips is the telemetry monitoring system and emergen is the communication software. All three manufacturers aware and working together with the hospital to identify root cause. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6076637 |
| MDR Report Key | 6076637 |
| Date Received | 2016-10-25 |
| Date of Report | 2016-10-25 |
| Date of Event | 2016-10-16 |
| Date Facility Aware | 2016-10-16 |
| Report Date | 2016-10-25 |
| Date Reported to FDA | 2016-10-25 |
| Date Reported to Mfgr | 2016-10-25 |
| Date Added to Maude | 2016-11-03 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VOALTE ONE VERSION 2.5.2 |
| Generic Name | VOALTE PHONE |
| Product Code | DXH |
| Date Received | 2016-10-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOALTE, INC. |
| Manufacturer Address | 5101 FRUITVILLE RD. STE. 200 SARATOSA FL 34232 US 34232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-10-25 |