MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for INTRAUTERINE PRESSURE CATHETER IUP-400 UNKNOWN manufactured by Utah Medical Products.
[20684284]
G1 po 42 weeks gestatin. Patient had been having rare variable decelerations and had begun to progress well in the early active phase of labor. A scalp electrode was placed and later an intrauterine pressure catheter was placed into postition. After the catheter placement, the mother developed a marked fetal bradycardia of between 21 and 27 audibly and visibly. This did not respond to oxygen, fluid or position change. The catheter was removed and the fetal bradycardia promptly disappeared.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16275 |
| MDR Report Key | 16275 |
| Date Received | 1994-02-04 |
| Date of Report | 1993-10-27 |
| Date of Event | 1993-08-19 |
| Date Facility Aware | 1993-10-14 |
| Report Date | 1993-10-27 |
| Date Reported to Mfgr | 1993-10-27 |
| Date Added to Maude | 1994-09-21 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | INTRAUTERINE PRESSURE CATHETER |
| Generic Name | FETAL MONITOR |
| Product Code | HGS |
| Date Received | 1994-02-04 |
| Model Number | IUP-400 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16208 |
| Manufacturer | UTAH MEDICAL PRODUCTS |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 84047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1994-02-04 |