MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-16 for CPOE/EHR DEVICE manufactured by Pro Touch/kindred.
[4921694]
Urine testing and culture was ordered but neither did reach the recipient to execute the order. There is not a user friendly program to reconcile the orders to determine exactly what was done or not done. Disease critical tests are delayed resulting in delays of treatment, threatening life and limb.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038289 |
| MDR Report Key | 4114511 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-06-21 |
| Date Added to Maude | 2014-09-25 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPOE/EHR DEVICE |
| Generic Name | CPOE/EHR |
| Product Code | NSX |
| Date Received | 2014-09-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRO TOUCH/KINDRED |
| Manufacturer Address | LOUISVILLE 40202 40202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other | 2014-09-16 |