MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-31 for OXYGEN-AIR BLENDER 78-8066-9202-2 NA manufactured by 3m Health Care Sarns And Cdi Products.
[89735]
During the bypass procedure, the surgical team noticed a gradual drop in the patient's venous oxygen saturation. Using the oxygen-air blender, they attempted to raise the saturation level, but they could not raise the level above 45%. It has since been confirmed that the oxygen-air blender had failed to deliver the specified concentration of oxygen to the patient. There has been no reported patient injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1828100-1997-00013 |
| MDR Report Key | 109568 |
| Report Source | 05 |
| Date Received | 1997-07-31 |
| Date of Report | 1997-07-30 |
| Date of Event | 1997-06-30 |
| Date Mfgr Received | 1997-07-01 |
| Device Manufacturer Date | 1995-03-01 |
| Date Added to Maude | 1997-08-01 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN-AIR BLENDER |
| Generic Name | OXYGEN-AIR BLENDER |
| Product Code | JRO |
| Date Received | 1997-07-31 |
| Returned To Mfg | 1997-07-01 |
| Model Number | 78-8066-9202-2 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| 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 | 107694 |
| Manufacturer | 3M HEALTH CARE SARNS AND CDI PRODUCTS |
| Manufacturer Address | 6200 JACKSON RD. ANN ARBOR MI 481039300 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1997-07-31 |