MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-29 for ORTHO-CLINICAL DIAGNOSTICS MODEL 120 INCUBATOR 1000-0014-0200 934090F manufactured by Fairway Medical Technologies.
[17870221]
The ortho-clinical diagnostics model 120 incubator power cord outer covering became cracked and frayed. The power cord is hard wired into the incubator. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2006-50514 |
| MDR Report Key | 950181 |
| Date Received | 2006-11-29 |
| Date of Report | 2006-11-29 |
| Date of Event | 2006-11-03 |
| Date Added to Maude | 2007-11-21 |
| 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 | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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-CLINICAL DIAGNOSTICS MODEL 120 INCUBATOR |
| Generic Name | MICROWELL PLATE INCUBATOR |
| Product Code | JTQ |
| Date Received | 2006-11-29 |
| Returned To Mfg | 2006-11-04 |
| Model Number | 1000-0014-0200 |
| Catalog Number | 934090F |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 921637 |
| Manufacturer | FAIRWAY MEDICAL TECHNOLOGIES |
| Manufacturer Address | 9431 W. SAM HOUSTON PKWY S. HOUSTON TX 77099 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-29 |