MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for SENTEC V-SIGN SDMS manufactured by Imagenix, Inc.
[106741661]
Patient Sequence No: 1, Text Type: N, H10
[106741662]
The sentec sensor insulation is prone to cracking and exposing large gaps that make it impossible to disinfect. Though the sensor is operational it cannot be used since it cannot be cleaned properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7468483 |
| MDR Report Key | 7468483 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-01-03 |
| Report Date | 2018-03-23 |
| Date Reported to FDA | 2018-03-23 |
| Date Reported to Mfgr | 2018-03-23 |
| Date Added to Maude | 2018-04-27 |
| 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 |
| 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 | SENTEC V-SIGN |
| Generic Name | OXIMETER, EAR |
| Product Code | DPZ |
| Date Received | 2018-04-27 |
| Model Number | SDMS |
| ID Number | VS-A/P/N |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMAGENIX, INC |
| Manufacturer Address | S65 W35739 PIPER RD. EAGLE WI 53119 US 53119 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-27 |