MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-09-06 for SINGLE HEAD GENESYS 2129-3011A NA manufactured by Adac Laboratories.
[267452]
The detector came into contact with the patient table and the collision detection system was not triggered. In order to halt all motions, a technologist pressed the system e-stop. The system did not contact the patient. There was no reported injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916556-2002-00030 |
| MDR Report Key | 415485 |
| Report Source | 05 |
| Date Received | 2002-09-06 |
| Date of Report | 2002-09-03 |
| Date of Event | 2002-07-31 |
| Date Mfgr Received | 2002-07-31 |
| Device Manufacturer Date | 1992-11-01 |
| Date Added to Maude | 2002-09-12 |
| 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 | JANICE BROWN |
| Manufacturer Street | 540 ALDER DRIVE |
| Manufacturer City | MILPITAS CA 950357443 |
| Manufacturer Country | US |
| Manufacturer Postal | 950357443 |
| Manufacturer Phone | 4084683766 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE HEAD GENESYS |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IXY |
| Date Received | 2002-09-06 |
| Model Number | 2129-3011A |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 404523 |
| Manufacturer | ADAC LABORATORIES |
| Manufacturer Address | 540 ALDER DRIVE MILPITAS CA 95035 US |
| Baseline Brand Name | GENESYS |
| Baseline Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Baseline Model No | 2129-3011A |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NUCLEAR MEDICINE EQUIPMENT |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K900689 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-09-06 |