MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-29 for KOALA INTRAUTERINE PRESSURE MONITORING KIT KOALA EXTERNAL REF-IPC-5000E manufactured by Clinical Innovations.
[5502222]
A koala intrauterine pressure catheter (iupc) did not work properly on pt. It would not show contractions properly. It would not read a baseline above 0. The same problem occurred on two other pts using iupcs from the same koala box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040570 |
| MDR Report Key | 4484048 |
| Date Received | 2015-01-29 |
| Date of Report | 2015-01-29 |
| Date of Event | 2015-01-23 |
| Date Added to Maude | 2015-02-05 |
| 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 | KOALA INTRAUTERINE PRESSURE MONITORING KIT |
| Generic Name | IUPC |
| Product Code | HFM |
| Date Received | 2015-01-29 |
| Model Number | KOALA EXTERNAL |
| Catalog Number | REF-IPC-5000E |
| Lot Number | 141071 |
| ID Number | +H833IPC50000E1 |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | MURRAY 84123 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-29 |