MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-06-29 for PET ADVANCE GANTRY 46-311001 NA manufactured by Ge Medical Systems.
[167441]
Manufacturing discovered a missing lock nut from the tilt mechanism of the pet advance gantry on some systems. This could potentially lead to failure of the tilt mechanism, which in some gantry orientations might result in unwanted tilt of the gantry toward the pt, possibly resulting in injury. There have been no reports of injury associated with this internal finding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-2000-00007 |
| MDR Report Key | 284748 |
| Report Source | 07 |
| Date Received | 2000-06-29 |
| Date of Report | 2000-06-29 |
| Date of Event | 2000-05-11 |
| Date Mfgr Received | 2000-05-11 |
| Date Added to Maude | 2000-07-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN KAY |
| Manufacturer Street | PO BOX 414 |
| Manufacturer City | MILWAUKEE WI 53201 |
| Manufacturer Country | US |
| Manufacturer Postal | 53201 |
| Manufacturer Phone | 2625134064 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PET ADVANCE GANTRY |
| Generic Name | NUCLEAR MEDICINE |
| Product Code | IYY |
| Date Received | 2000-06-29 |
| Model Number | 46-311001 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 275556 |
| Manufacturer | GE MEDICAL SYSTEMS |
| Manufacturer Address | 3000 N GRANDVIEW BLVD WAUKESHA WI 53188 US |
| Baseline Brand Name | PET ADVANCE GANTRY |
| Baseline Generic Name | NUCLEAR MEDICINE |
| Baseline Model No | 46-311001 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-06-29 |