MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-10-11 for BAYER ADVIA 120 SYSTEM 254 manufactured by Bayer Diagnostics Mfg. Ltd, Swords, Co..
[256678]
In 02, pt was performing maintenance on the advia 120 system with the upper lid open to allow better access to the closed tube area. The lid fell on pt's head. Pt felt dizzy and had head pain. Pt went home to rest and nap. Pt went to employee health who have reported that pt was ok but may have had a slight concussion. Bayer was notified. Based on the available data, bayer's medical director indicated that an mdr should be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2002-00007 |
| MDR Report Key | 421929 |
| Report Source | 05 |
| Date Received | 2002-10-11 |
| Date of Report | 2002-10-10 |
| Date of Event | 2002-09-11 |
| Date Mfgr Received | 2002-09-12 |
| Device Manufacturer Date | 1998-12-01 |
| Date Added to Maude | 2002-10-17 |
| 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 | CAROL BIANCA, MANAGER |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242531 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAYER ADVIA 120 SYSTEM |
| Generic Name | HEMATOLOGY SYSTEM |
| Product Code | GLK |
| Date Received | 2002-10-11 |
| Model Number | ADVIA 120 |
| Catalog Number | 254 |
| Lot Number | NA |
| 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 | 410983 |
| Manufacturer | BAYER DIAGNOSTICS MFG. LTD, SWORDS, CO. |
| Manufacturer Address | CHAPEL LANE DUBLIN EI |
| Baseline Brand Name | ADVIA 120 |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K971998 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-10-11 |