MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-08-27 for ARC 2129-3015A NA manufactured by Adac Laboratories.
[136191]
The detector rotated at "high speed" around the pt and appeared to drift toward the pt during a static study.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2916556-1999-00085 |
MDR Report Key | 238135 |
Report Source | 07 |
Date Received | 1999-08-27 |
Date of Report | 1997-04-09 |
Date of Event | 1997-04-09 |
Date Mfgr Received | 1997-04-09 |
Date Added to Maude | 1999-09-02 |
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, DIRECTOR 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 DRIVE |
Manufacturer City | MILPITAS CA 95035744 |
Manufacturer Country | US |
Manufacturer Postal Code | 95035 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 | 1999-08-27 |
Model Number | 2129-3015A |
Catalog Number | NA |
Lot Number | * |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 230769 |
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 | 2129-3015A |
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 | 1999-08-27 |