MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-10-30 for DUAL HEAD GENESYS 2144-3000A NA manufactured by Adac Laboratories.
[17109416]
It was reported to adac that after the collision sensor stopped the gantry movement, system could not be placed into override and moved away due to the condition of the patient. Hospital personnel contacted adac and were instructed to shut the system off and manually roll the gantry away. While pushing the gantry away, patient's center line was inadvertently pulled out. Hospital personnel reported that the patient's condition stablized within 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916556-2000-00358 |
| MDR Report Key | 303260 |
| Report Source | 05 |
| Date Received | 2000-10-30 |
| Date of Report | 2000-10-24 |
| Date of Event | 2000-10-16 |
| Date Mfgr Received | 2000-10-16 |
| Date Added to Maude | 2000-11-07 |
| 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 | 3 |
| Manufacturer Contact | CLIFF CASE, DIR. |
| Manufacturer Street | 540 ALDER DRIVE |
| Manufacturer City | MILPITAS CA 950357443 |
| Manufacturer Country | US |
| Manufacturer Postal | 950357443 |
| Manufacturer Phone | 4084683151 |
| Manufacturer G1 | ADAC LABORATORIES |
| Manufacturer Street | 540 ALDER DRIVE |
| Manufacturer City | MILPITAS CA 95035744 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 7443 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUAL HEAD GENESYS |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IXY |
| Date Received | 2000-10-30 |
| Model Number | 2144-3000A |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 293501 |
| Manufacturer | ADAC LABORATORIES |
| Manufacturer Address | 540 ALDER DRIVE MILPITAS CA 950357443 US |
| Baseline Brand Name | GENESYS |
| Baseline Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Baseline Model No | 2144-3000A |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NUCLEAR MEDICINE EQUIPMENT |
| 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 | 2000-10-30 |