MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-09 for MEDICAL COMPUTER AND SOFTWARE manufactured by .
[47250417]
The pt was seen in the post op anesthesia care area (pacu). Post op electronic orders were not released while pt was in pacu, and then pt was transferred to med surg. After transfer the pacu orders were released. The usual method was bypassed, and the post op orders did not auto d/c upon transfer. This left the medication and dosages active on the mar for the post op pt, which presented a potential risk for giving a medication not ordered, and in dosages not appropriate for the pt's location and level of care. This has occurred on a number of occasions and staff are being educated to the problem and potential risks. Medication not administered to or used by the pt. Relevant materials not provided. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062757 |
| MDR Report Key | 5719804 |
| Date Received | 2016-06-09 |
| Date of Report | 2016-04-05 |
| Date Added to Maude | 2016-06-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | MEDICAL COMPUTER AND SOFTWARE |
| Generic Name | MEDICAL COMPUTER AND SOFTWARE |
| Product Code | NSX |
| Date Received | 2016-06-09 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-09 |