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 2011-06-15 for EAGLE 4000 PATIENT MONITOR manufactured by Ge Healthcare.
[2136897]
It was reported that an asystole event occurred without an audible alarm at the eagle 4000 bedside monitor or the clinical information center (cic). A visual asystole alarm was displayed at the bedside monitor and at the cic. The cic log files show that vfib-vtach alarms were provided at 50% volume and that alarms were silenced numerous times at the bedside and at the cic. No ecg strips are available. There was no reported patient injury associated with this event. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
[9252905]
The device manufacture date is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124823-2011-00097 |
| MDR Report Key | 2175228 |
| Report Source | 01,05,06 |
| Date Received | 2011-06-15 |
| Date of Report | 2011-06-15 |
| Date of Event | 2011-05-16 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2011-08-31 |
| 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 | GE HEALTHCARE |
| Manufacturer City | MILWAUKEE WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EAGLE 4000 PATIENT MONITOR |
| Generic Name | PATIENT MONITORING SYSTEM |
| Product Code | LOS |
| Date Received | 2011-06-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | MILWAUKEE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-15 |