MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-07-16 for SINO POWER -S manufactured by Ge Medical Systems, Llc.
[20455051]
During a ct examination of the thorax, abdomen and pelvis, it was reported that there were four incidents of paravenous injection of the contrast substance while using the contrast injector "sino power -s"; serial number (b)(4). Surgical intervention was necessary in order to avoid compressive lodge syndrome. The sino power -s is neither designed nor manufactured by ge healthcare, but ge healthcare is the distributor/importer of this component.
Patient Sequence No: 1, Text Type: D, B5
[20570505]
Approximate age of the device is unk. 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: N, H10
| Report Number | 2126677-2014-00013 |
| MDR Report Key | 3975104 |
| Report Source | 99 |
| Date Received | 2014-07-16 |
| Date of Report | 2014-06-16 |
| Date of Event | 2014-06-16 |
| Date Facility Aware | 2014-06-16 |
| Report Date | 2014-06-16 |
| Date Reported to FDA | 2014-07-16 |
| Date Reported to Mfgr | 2014-07-16 |
| Date Added to Maude | 2014-08-05 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINO POWER -S |
| Generic Name | NONE |
| Product Code | IZQ |
| Date Received | 2014-07-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-16 |