MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-02-27 for CARESCAPE CENTRAL STATION V2 2092670-001 manufactured by Critikon De Mexico S. De R.l. De C.v..
[137310378]
Unique identifier (udi): (b)(4). Ge healthcare's investigation is on-going at this time; a follow-up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[137310379]
It was reported the device did not provide audible alarms and the patient was found deceased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008729547-2019-00001 |
| MDR Report Key | 8374710 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-02-27 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-04-17 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-02-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTOF SOOS |
| Manufacturer Street | 8200 W. TOWER AVE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARESCAPE CENTRAL STATION V2 |
| Generic Name | DISPLAY, CATHODE-RAY TUBE, MEDICAL |
| Product Code | DXJ |
| Date Received | 2019-02-27 |
| Model Number | 2092670-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | CALLE VALLE DEL CEDRO 1551 JUAREZ 32575 MX 32575 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-02-27 |