MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-12-30 for ARC 2129-3008C NA manufactured by Adac Laboratories.
[18198651]
During a collimator exchange, the megp septa fell out of the collimator when it was 1/8 inch above the detector face. No personnel were injured and no patients were involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916556-1999-00231 |
| MDR Report Key | 257071 |
| Report Source | 05 |
| Date Received | 1999-12-30 |
| Date of Report | 1999-12-30 |
| Date of Event | 1999-11-29 |
| Date Mfgr Received | 1999-12-01 |
| Date Added to Maude | 2000-01-04 |
| 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, DIR. OF RA |
| Manufacturer Street | 540 ALDER DRIVE |
| Manufacturer City | MILPITAS CA 950357443 |
| Manufacturer Country | US |
| Manufacturer Postal | 950357443 |
| Manufacturer Phone | 4084683766 |
| Manufacturer G1 | ADAC LABORATORIES |
| Manufacturer Street | 540 ALDER DRIVEQ |
| Manufacturer City | MILPITAS CA 99035744 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 99035 7443 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARC |
| Generic Name | NUCLEAR MEDICINE EQUIPMENT |
| Product Code | JWM |
| Date Received | 1999-12-30 |
| Model Number | 2129-3008C |
| 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 | 248945 |
| Manufacturer | ADAC LABORATORIES |
| Manufacturer Address | 540 ALDER DR. MILPITAS CA 950357443 US |
| Baseline Brand Name | ARC |
| Baseline Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
| Baseline Model No | 2129-3008C |
| 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 | K874473 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-12-30 |