MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-27 for * manufactured by Non Invasive Medical Technologies.
[416411]
This device is used to monitor fluid accumulation in the chest of chf pts who have been in and out of the hosp on two or more occasions in the last six months. A pilot study was done and it was found that the cables had problems. There were no readings on the machine. Three cables were replaced on two occasions but there were no readings on the monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037476 |
| MDR Report Key | 661565 |
| Date Received | 2005-12-27 |
| Date of Report | 2005-12-27 |
| Date Added to Maude | 2006-01-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | ZOE-BIO IMPEDANCE MONITOR |
| Product Code | DSB |
| Date Received | 2005-12-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | PN 41610/H1117/G1239 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 650973 |
| Manufacturer | NON INVASIVE MEDICAL TECHNOLOGIES |
| Manufacturer Address | 3201 UNIVERSITY DR STE 360 AUBURN HILLS MI 48326 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-27 |