MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-02 for 4000 SOFTRANS IUPC * 31103826 manufactured by Kendall Ltp.
[183298]
On two different pts, the intrauterine pressure catheter provided questionable varying and false readings on the efm. For one pt the resting tone should have been at 15-20 mm/hg. The intrauterine pressure catheter used showed 40mm/hg. The pt's uterus felt soft during this time. Action was taken to change intrauterine pressure catheter, rezero and check connections.
Patient Sequence No: 1, Text Type: D, B5
[201186]
Add'l info rec'd from mfr 11/13/00: mfr is not able to determine a root cause for the baseline issues experienced by hosp. Mfr notes that no subsequent issues were encountered. This supports the position that improper zeroing or rezeroing technique may have contributed to the baseline issue. Devices were not returned to mfr. The devices may not be used in a pt for more than 24 hrs, so it is probable that the devices were disposed of.
Patient Sequence No: 1, Text Type: D, B5
[6082194]
On two different pts, the intrauterine pressure catheter provided questionable varying and false readings on the efm. For one pt the resting tone should have been at 15-20 mm/hg. The intrauterine pressure catheter used showed 40mm/hg. The pt's uterus felt soft during this time. Action was taken to change intrauterine pressure catheter, rezero and check connections.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | MW1020057 |
| MDR Report Key | 298919 |
| Date Received | 2000-10-02 |
| Date of Report | 2000-09-25 |
| Date of Event | 2000-09-16 |
| Date Added to Maude | 2000-10-05 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4000 SOFTRANS IUPC |
| Generic Name | INTRAUTERINE PRESSURE MONITORING SYSTEM |
| Product Code | KXO |
| Date Received | 2000-10-02 |
| Model Number | * |
| Catalog Number | 31103826 |
| Lot Number | 010279 |
| ID Number | REORDER/PART NO: 31103826 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 289349 |
| Manufacturer | KENDALL LTP |
| Manufacturer Address | 189 VAN RENSSELAER ST PO BOX 1274 BUFFALO NY 142401274 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-02 |
| 2 | 0 | 1. Other | 2000-10-02 |