MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-07-07 for GENESYS 2144-3002A NA manufactured by Adac Laboratories.
[187558]
There is a hairline crack in the neck end of the dhg epic table. There are no reports of injury to the patient or the customer.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2916556-2000-00298 |
MDR Report Key | 285209 |
Report Source | 05 |
Date Received | 2000-07-07 |
Date of Event | 2000-06-08 |
Date Facility Aware | 2000-06-08 |
Report Date | 2000-06-08 |
Date Mfgr Received | 2000-06-08 |
Date Added to Maude | 2000-07-12 |
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 DR |
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 | GENESYS |
Generic Name | NUCLEAR MEDICINE EQUIPMENT |
Product Code | IXY |
Date Received | 2000-07-07 |
Model Number | 2144-3002A |
Catalog Number | NA |
Lot Number | NA |
ID Number | 6495H |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | NA |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 276010 |
Manufacturer | ADAC LABORATORIES |
Manufacturer Address | 540 ALDER DR MILPITAS CA 950357443 US |
Baseline Brand Name | GENESYS |
Baseline Generic Name | NUCLEAR MEDICINE GAMMA CAMERA |
Baseline Model No | 2129-3010X |
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 | 2000-07-07 |