MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for NOVAPLUS DIGITAL THERMOMETER VDST-100D manufactured by Ekla Corporation.
[184276718]
Rn obtained rectal temperature on pediatric patient multiple times in initial 4 hours of shift. Patient temperature read 98. 6 or 98. 7 each time. Patient has having difficulty breathing and felt warm to the touch. Rn attempted an alternative route and utilized temporal thermometer which read 100. 4. New rectal thermometer obtained and temperature read 100. 0. Manufacturer response for digital thermometer, novaplus digital thermometer (per ekla site reporter). Customer service (b)(4) notified of equipment failure. It appeared the lot number was expired. At the request of ekla, i verified that we did not have another thermometer of the same lot number on our shelf.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859709 |
| MDR Report Key | 9859709 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-18 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| 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 | 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 |
| Brand Name | NOVAPLUS DIGITAL THERMOMETER |
| Generic Name | DIGITAL THERMOMETER |
| Product Code | FLL |
| Date Received | 2020-03-20 |
| Catalog Number | VDST-100D |
| Lot Number | 20151230 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EKLA CORPORATION |
| Manufacturer Address | 1707 QUINCY AVE. SUITE 127 NAPERVILLE IL 60540 US 60540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |