MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for DISCOVERY NM 630 5409004-06 H3100J2 manufactured by Ge Healthcare.
[120244174]
We had a ge nuclear medicine camera installed in our department in (b)(6) 2018. One of the studies we do is a kidney study and we did approximately 25 of those studies from (b)(6) 2018 - (b)(6) 2018. As part of the kidney study we look at what is the percentage function of each kidney which is called the split renal function. When the ge clinical application specialist was here, she stated to our department that the split renal function is the perfusion percentage that is calculated by the computer. With time we realized that this seemed incorrect and last week we confirmed with ge that it is not the perfusion percentage but is the percent uptake that is calculated by the computer. Thus the number was incorrectly reported on those patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079705 |
| MDR Report Key | 7868519 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-09-04 |
| Date Added to Maude | 2018-09-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DISCOVERY NM 630 |
| Generic Name | NM GANTRY |
| Product Code | KPS |
| Date Received | 2018-09-11 |
| Model Number | 5409004-06 H3100J2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | CLEVELAND OH 44128 US 44128 |
| Brand Name | DISCOVERY NM 630 |
| Generic Name | NM GANTRY |
| Product Code | JAK |
| Date Received | 2018-09-11 |
| Model Number | 5409004-06 H3100J2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Manufacturer Address | CLEVELAND OH 44128 US 44128 |
| Brand Name | OPTIMA NM/CT 640 |
| Generic Name | NM GANTRY |
| Product Code | JAK |
| Date Received | 2018-09-11 |
| Model Number | 5363260-12 H3100J2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Manufacturer Address | CLEVELAND OH 44128 US 44128 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-11 |