MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-17 for DISCOVERY MI PDBB01 manufactured by Ge Medical Systems, Llc.
[176612127]
Unique identifier: (b)(4). Legal manufacturer: (b)(4). Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[176612128]
It was reported that a patient's chemotherapy plan was de-escalated because comparative images were diagnosed as a false negative condition. Per customer communication on (b)(6) 2019, as a result of this altered treatment plan, her lymphoma has progressed. Ge healthcare's investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2020-00001 |
| MDR Report Key | 9603809 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-17 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2020-01-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | SUSAN STRASSER |
| Manufacturer Street | 3000 N GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY MI |
| Generic Name | SYSTEM,TOMOGRAPHY,COMPUTED,EMISSION |
| Product Code | KPS |
| Date Received | 2020-01-17 |
| Model Number | PDBB01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 3000 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-17 |