MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-09-12 for VIDAS VIDAS 30 W2010 manufactured by Biomerieux, Inc..
[15029869]
Customer complained of obtaining three incorrect results. Field svc confirmed pump failure and replaced the pump. U. S. Engineering confirmed that the pump was clogged.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1950204-2001-00014 |
MDR Report Key | 351841 |
Report Source | 01 |
Date Received | 2001-09-12 |
Date of Report | 2001-09-12 |
Date of Event | 2001-09-05 |
Date Mfgr Received | 2001-09-05 |
Device Manufacturer Date | 1996-01-01 |
Date Added to Maude | 2001-09-19 |
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 | SANDRA PERREAND |
Manufacturer Street | 595 ANGLUM DRIVE |
Manufacturer City | HAZELWOOD MO 63042 |
Manufacturer Country | US |
Manufacturer Postal | 63042 |
Manufacturer Phone | * |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Remedial Action | RP |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VIDAS |
Generic Name | IMMUNOFLUROMETRIC EQUIPMENT |
Product Code | JZT |
Date Received | 2001-09-12 |
Model Number | VIDAS 30 |
Catalog Number | W2010 |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | Y |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 341122 |
Manufacturer | BIOMERIEUX, INC. |
Manufacturer Address | 595 ANGLUM DR. HAZELWOOD MO 63042 US |
Baseline Brand Name | VIDAS |
Baseline Generic Name | IMMUNOFLUOROMETER EQUIPMENT |
Baseline Model No | VIDAS 30 |
Baseline Catalog No | W2010 |
Baseline ID | NA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2001-09-12 |