MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-16 for ORTHO SUMMIT PROCESSOR 7003015 936480 manufactured by Ortho-clinical Diagnostics.
[275527]
Customer reported a washer module lockup with ortho summit processor and that the last 3 rows of an ortho hcv 3. 0 plate were not washed. The instrument did not invalidate the wells. Test results for these wells would have been reactive, since the conjugate was not removed from the wells. An fse was dispatched and the washer manifold and boards were replaced. Diagnostic checks were performed to verify that the instrument was operating properly after repair. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2002-00569 |
| MDR Report Key | 397302 |
| Date Received | 2002-05-16 |
| Date of Report | 2002-05-14 |
| Date of Event | 2002-03-28 |
| Date Facility Aware | 2002-04-01 |
| Report Date | 2002-04-06 |
| Date Reported to Mfgr | 2002-05-14 |
| Date Added to Maude | 2002-06-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO SUMMIT PROCESSOR |
| Generic Name | SAMPLE PROCESSOR |
| Product Code | JTL |
| Date Received | 2002-05-16 |
| Model Number | 7003015 |
| Catalog Number | 936480 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 386355 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1001 US HWY 2002 RARITAN NJ 088690606 US |
| Baseline Brand Name | ORTHO SUMMIT PROCESSOR |
| Baseline Generic Name | SAMPLE PROCESSOR |
| Baseline Model No | 7003015 |
| Baseline Catalog No | 936480 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-16 |