MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-04 for SYSMEX COAGULATION ANALYZER CA-1000 B4260-1000 manufactured by Toa Medical Electronics Co..
[21194]
Customer complained that the plastic tip from the end of the thromboplastin reagent pump tubing no 4 is slipping off. Customer claims that they were reporting pt values during this incident, but no specific info is available. There is no info to suggest that pt treatment was altered as a result of this incident. Event date: early 12/95.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017272-1996-00004 |
| MDR Report Key | 31483 |
| Date Received | 1996-03-04 |
| Date of Report | 1996-03-01 |
| Date Facility Aware | 1996-02-14 |
| Report Date | 1996-03-01 |
| Date Reported to FDA | 1996-03-01 |
| Date Reported to Mfgr | 1996-03-01 |
| Date Added to Maude | 1996-03-29 |
| 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 | SYSMEX COAGULATION ANALYZER |
| Generic Name | COAGULATION ANALYZER |
| Product Code | KQG |
| Date Received | 1996-03-04 |
| Model Number | CA-1000 |
| Catalog Number | B4260-1000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 32632 |
| Manufacturer | TOA MEDICAL ELECTRONICS CO. |
| Manufacturer Address | 4-4-4 TAKATSUBADAI NISHI-KU, KOBE JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-03-04 |