MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-25 for DUKANE PROCARE 6000 * manufactured by Ge Healthcare.
[20856707]
Nurse call system on post-partum not working. Power down, uninterruptable power supply (ups) is not functioning properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3313868 |
| MDR Report Key | 3313868 |
| Date Received | 2012-10-25 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-09-26 |
| Report Date | 2012-10-25 |
| Date Reported to FDA | 2012-10-25 |
| Date Reported to Mfgr | 2012-11-08 |
| Date Added to Maude | 2013-08-28 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUKANE |
| Generic Name | NURSE CALL SYSTEM |
| Product Code | ILQ |
| Date Received | 2012-10-25 |
| Model Number | PROCARE 6000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 9900 W. INNOVATION DRIVE, RP21 WAUWATOSA WI 53226 US 53226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-25 |