MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-14 for OHMEDA PULSE OXIMETER B10 X 3740 manufactured by Ohmedia Monitoring Systems.
[10622]
Blackened area on rt foot noted. Pulse ox probe changed. The following day another site was found to be warm on rotation of the probe. Pulse ox unit sent to biomedical engineering for evaluation. Infant sustained a. 5x. 5 cm blacked area on foot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 15385 |
| MDR Report Key | 15385 |
| Date Received | 1994-01-14 |
| Date of Report | 1993-11-08 |
| Date of Event | 1993-10-14 |
| Date Facility Aware | 1993-10-22 |
| Report Date | 1993-11-08 |
| Date Added to Maude | 1994-08-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | OHMEDA PULSE OXIMETER |
| Generic Name | PULSE OXIMETER UNIT |
| Product Code | MMA |
| Date Received | 1994-01-14 |
| Model Number | B10 X 3740 |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15379 |
| Manufacturer | OHMEDIA MONITORING SYSTEMS |
| Manufacturer Address | 1315 W. CENTURY DR. LOUISVILLE CO 800279560 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-14 |