MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-08-16 for VERTEX VERTEX PLUS MANUAL 2149-3001A manufactured by Adac Laboratories.
[158189]
A ring lock error occurred that required that recovery be initiated in svc mode. The procedure was incorrectly performed by the fse resulting in head 2 swinging freely. There was no pt in the equipment at the time of the event. The operators' manual states that the pt should not be on the table during operation of the ring locks. There were no injuries to users, pts, or other personnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916556-1999-00077 |
| MDR Report Key | 236804 |
| Report Source | 07 |
| Date Received | 1999-08-16 |
| Date of Report | 1999-07-18 |
| Date of Event | 1999-07-18 |
| Date Mfgr Received | 1999-07-18 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 1999-08-25 |
| 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 | 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 | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTEX |
| Generic Name | * |
| Product Code | IYY |
| Date Received | 1999-08-16 |
| Model Number | VERTEX PLUS MANUAL |
| Catalog Number | 2149-3001A |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 229486 |
| Manufacturer | ADAC LABORATORIES |
| Manufacturer Address | 540 ALDER DR. MILPITAS CA 950357443 US |
| Baseline Brand Name | VERTEX PLUS MANUAL EXCHANGER |
| Baseline Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Baseline Model No | VERTEX PLUS MAN |
| Baseline Catalog No | 2149-3001A |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-08-16 |