MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-07 for VYNTUS/ SENTRYSUITE PRODUCT LINE VYNTUS CPX 29871-001 manufactured by Carefusion, Inc.
[76958401]
(b)(4). The carefusion field service representative (fsr) went onsite to evaluate the device. The fsr identified that the customer had replaced the bluetooth electrocardiogram (ecg) with cardiosoft cam. The fsr reconfigured the treadmill set up to use the cardiosoft product and the reported issue was resolved. All devices were verified to be working properly after reconfiguration.
Patient Sequence No: 1, Text Type: N, H10
[76958402]
The customer reported having issues with the sentrysuite software. The bluetooth is not connecting, the system froze, and it turned off the treadmill. The device was in use on a patient at the time of the incident but there was no harm reported and no intervention required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2017-06099 |
| MDR Report Key | 6620550 |
| Date Received | 2017-06-07 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-05-11 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2017-06-07 |
| 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 | KRISTIN GRAF |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | LIEBNIZSTRASSE 7 |
| Manufacturer City | HOECHBERG 97204 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 97204 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VYNTUS/ SENTRYSUITE PRODUCT LINE |
| Generic Name | CALCULATOR, PULMONARY FUNCTION DATA |
| Product Code | BZC |
| Date Received | 2017-06-07 |
| Model Number | VYNTUS CPX |
| Catalog Number | 29871-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-07 |