MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-02-01 for DUAL HEAD GENESYS 2144-3000B manufactured by Adac Laboratories.
[241489]
It was reported to adac that a pts hair wrapped around the lead screw several times. Technologists was alarmed by the pt and the emergency stop was immediately activated. Pt's hair that was entwined on the screw was then cut off by the technologist. There were no reported injuries as result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916556-2002-00005 |
| MDR Report Key | 375521 |
| Report Source | 05 |
| Date Received | 2002-02-01 |
| Date of Report | 2002-01-24 |
| Date of Event | 2001-12-15 |
| Date Mfgr Received | 2002-01-09 |
| Device Manufacturer Date | 1994-01-01 |
| Date Added to Maude | 2002-02-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANICE BROWN |
| Manufacturer Street | 540 ALDER DR |
| 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 | DUAL HEAD GENESYS |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | IXY |
| Date Received | 2002-02-01 |
| Model Number | 2144-3000B |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 364601 |
| Manufacturer | ADAC LABORATORIES |
| Manufacturer Address | 540 ALDER DR MILPITAS CA 950377443 US |
| Baseline Brand Name | GENESYS |
| Baseline Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Baseline Model No | 2144-3000B |
| 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 | 2002-02-01 |