MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-01-24 for NELLCOR * manufactured by Tyco Healthcare.
[403799]
Problem involves 2 nellcor oximax infant oxygen sensors that have been reprocessed by vanguard medical concepts. Rn reports on at least two different occasions the wires have become exposed next to the bandaid portion that wraps around the infant's big toe. No injury to the pts at this time. Both products removed from service immediately when the frayed wires were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037816 |
| MDR Report Key | 678080 |
| Date Received | 2006-01-24 |
| Date of Report | 2006-01-24 |
| Date of Event | 2006-01-23 |
| Date Added to Maude | 2006-02-24 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NELLCOR |
| Generic Name | OXIMAX INFANT OXYGEN SENSOR |
| Product Code | CCL |
| Date Received | 2006-01-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 667351 |
| Manufacturer | TYCO HEALTHCARE |
| Manufacturer Address | 4280 HACIENDA DR PLEASANTON CA 94588 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-01-24 |