MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-07-01 for DASH 2000 manufactured by Critikon De Mexico S. De R.l. De C.v..
[2141053]
It was reported that a spontaneous reboot of the dash 2000 bedside monitor occurred. There was no serious injury or death associated with this event, nor was medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[9244969]
Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed. The device manufacture date is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008729547-2011-00002 |
| MDR Report Key | 2177831 |
| Report Source | 01,05,06 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-07-01 |
| Date of Event | 2011-05-31 |
| Date Mfgr Received | 2011-06-07 |
| Date Added to Maude | 2011-09-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer City | JUAREZ |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DASH 2000 |
| Generic Name | PHYSIOLOGICAL PATIENT MONITOR |
| Product Code | LOS |
| Date Received | 2011-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITIKON DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | JUAREZ 0000 MX 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-01 |