MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-29 for KOALA EXTERNAL CABLE/CATH 129 manufactured by Clinical Innovations.
[5568004]
A koala intrauterine pressure catheter (iupc) did not work properly on patient; would not show contractions properly. Would not read a baseline above 0. The same problem occurred on two other patients using iupc's from the same koala box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040569 |
| MDR Report Key | 4484047 |
| Date Received | 2015-01-29 |
| Date of Report | 2015-01-29 |
| Date of Event | 2015-01-27 |
| 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 EXTERNAL CABLE/CATH |
| Generic Name | IUPC |
| Product Code | HFM |
| Date Received | 2015-01-29 |
| Model Number | 129 |
| Lot Number | 141168 |
| Device Expiration Date | 2016-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-29 |