MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-26 for CARESCAPE CENTRAL STATION V2 2092670-001 manufactured by Critikon De Mexico S. De R.l. De C.v..
[115367568]
(b)(4). No specific patient was involved; the device may be used to monitor multiple patients; the customer did not specify how many patients were being monitored on the device at the time of the event. However, it was clarified that the patient(s) were also being monitored on another device at that time. Ge healthcare's investigation is on-going at this time. A follow-up report will be sent when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[115367569]
The customer reported smoke and a burning smell emitted from the device. There was no related adverse patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008729547-2018-00004 |
| MDR Report Key | 7723613 |
| Date Received | 2018-07-26 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-09-21 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2018-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | CARESCAPE CENTRAL STATION V2 |
| Generic Name | DISPLAY, CATHODE-RAY TUBE, MEDICAL |
| Product Code | DXJ |
| Date Received | 2018-07-26 |
| Model Number | 2092670-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 |
| Brand Name | CARESCAPE CENTRAL STATION V2 |
| Generic Name | DISPLAY, CATHODE-RAY TUBE, MEDICAL |
| Product Code | DXJ |
| Date Received | 2018-07-26 |
| Model Number | 2092670-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-07-26 |