Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-03-27 | VAI | Voluntary action indicated | Curbell Medical Products, Inc. | 2 |
| 2017-03-27 | VAI | Voluntary action indicated | Curbell Medical Products, Inc. | 2 |
| 2014-10-09 | NAI | No action indicated | Curbell Medical Products, Inc. | 0 |
| 2014-10-09 | NAI | No action indicated | Curbell Medical Products, Inc. | 0 |
| 2012-04-09 | VAI | Voluntary action indicated | Curbell Medical Products, Inc. | 3 |
| 2012-04-09 | VAI | Voluntary action indicated | Curbell Medical Products, Inc. | 3 |
Similar devices
- ECG cable Edan Instruments, Inc.
- ECG limb cable Edan Instruments, Inc.
- ECG limb wires Edan Instruments, Inc.
- ECG limb wires Edan Instruments, Inc.
- Interm Cbl Trident (NMT), 1.9m DRAEGER MEDICAL SYSTEMS, INC.
- Philips APK Technology Co.,Ltd.
- "Temp Adapt Cable 7-pin to 1/4""" DRAEGER MEDICAL SYSTEMS, INC.
- 10 LEADWIRE SET - CAM14/BN RPI
- 10 LEADWIRE SET - CAM14/PI RPI
- 10 LEADWIRE SET - CAM14/SN RPI
- 3 LEADWIRE SET - 24"DN/PI RPI
- 3 LEADWIRE SET - 24"DN/PI RPI
Select up to two to place side-by-side with this device.