MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for DASH 3000 PATIENT MONITOR manufactured by Ge Healthcare.
[174714082]
Patient was in for a bone marrow biopsy with anesthesia. Physician had administered propofol and was monitoring the patient using the dash monitor. The monitor turned off and would not come back on. Biopsy of bone marrow was completed. There was no known patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9580325 |
| MDR Report Key | 9580325 |
| Date Received | 2020-01-13 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-08-19 |
| Report Date | 2019-12-30 |
| Date Reported to FDA | 2019-12-30 |
| Date Reported to Mfgr | 2020-01-13 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | DASH 3000 PATIENT MONITOR |
| Generic Name | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| Product Code | MWI |
| Date Received | 2020-01-13 |
| Model Number | DASH 3000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 3000 N. GRANDVIEW BLVD WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |