MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-20 for GENESIS BPS CM350 manufactured by Genesis Bps.
[17972481]
A patient was receiving a phlebotomy procedure with the blood collection device on the scale when the scale turned off in the middle of the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2545702 |
| MDR Report Key | 2545702 |
| Date Received | 2012-04-20 |
| Date of Report | 2012-04-16 |
| Date of Event | 2012-03-14 |
| Report Date | 2012-04-16 |
| Date Reported to FDA | 2012-04-20 |
| Date Added to Maude | 2012-04-24 |
| 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 | 3 |
| 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 | GENESIS BPS |
| Generic Name | GENESIS BLOOD COLLECTION MONITOR |
| Product Code | KSQ |
| Date Received | 2012-04-20 |
| Model Number | CM350 |
| Catalog Number | CM350 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENESIS BPS |
| Manufacturer Address | 650 COMMERCE WAY HACKENSACK NJ 08005 US 08005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-20 |