MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for NUPULSE NDU manufactured by Nupulse Cv, Inc..
[183517537]
Rn was in pt's room and heard alarm sounding. Nupulse was not inflating and deflating at this time, rn called charge rn. Np was also called to bedside. Alarm on screen was "attention (4). Battery fault. " per nupulse binder, external battery was changed. Device still not functioning with battery exchange. Pt was switched to back up navigation distribution unit. Nupulse now functioning at this time. Pt asymptomatic throughout. Upon assessment, battery life was 6 hrs and 21 mins, external battery was 97% and internal battery was 91% charged. Nupulse hotline called and updated. Rns advised to contact research team- called and aware. She will bring pt's discharge kit with backup navigation distribution unit to bedside tomorrow am. For tonight, md brought back up ndu slated for or case tomorrow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9835251 |
| MDR Report Key | 9835251 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-28 |
| Report Date | 2020-03-06 |
| Date Reported to FDA | 2020-03-06 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Generic Name | NUPULSE NDU |
| Product Code | KMA |
| Date Received | 2020-03-16 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUPULSE CV, INC. |
| Manufacturer Address | 5734 TRINITY ROAD SUITE 101 RALEIGH NC 27607 US 27607 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |