MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-30 for CBL SPO2 SENSOR manufactured by Drager Medical.
[630562]
Monitor indicated ok o2 saturation and pulse, even though probe was off of patient. This issue was reproduced in the biomed department -not on patient-. This was photographed and documented. Product defect was reported to manufacturer through quality department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002126 |
| MDR Report Key | 859327 |
| Date Received | 2007-05-30 |
| Date of Report | 2007-05-30 |
| Date of Event | 2007-03-22 |
| Date Added to Maude | 2007-06-11 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CBL SPO2 SENSOR |
| Generic Name | SPO2 ADAPTOR |
| Product Code | CCL |
| Date Received | 2007-05-30 |
| Returned To Mfg | 2007-04-22 |
| Lot Number | 3368433-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 845192 |
| Manufacturer | DRAGER MEDICAL |
| Manufacturer Address | 3135 QUARRY RD. TELFORD PA 18969 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-30 |