MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for SOARIAN manufactured by Siemens.
[23542061]
Arterial blood gas was ordered via cpoe system because of obtundation in pt with a history of respiratory failure. More than 24 hours later, the test was listed as "in progress", though there was not any result. There was not any notification by the ehr machine that there was not a result; nor did the nurses in the icu know there was not a result; nor did the team responsible for obtaining the blood sample obtain the sample. The order was some place in the silos of the cpoe computer. The pt deteriorated requiring intubation and mechanical ventilation and went into shock as a result of the delay in diagnosis of acute respiratory failure. It is a widespread phenomena that ancillary do not get random orders and there is not any warning or indication by the device that an order remains outstanding. The life threatening complications of this defect are frequent and have been occurring for ten years or more. Nothing has been done to correct this defective device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5045109 |
| MDR Report Key | 4974698 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-31 |
| Date of Event | 2015-07-26 |
| Date Added to Maude | 2015-08-05 |
| 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 | 0 |
| Brand Name | SOARIAN |
| Generic Name | CPOE/EHR |
| Product Code | NSX |
| Date Received | 2015-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2015-07-31 |