MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-25 for COROMETRICS 115 manufactured by Corometrics.
[19662839]
Fetal demise after approximately 10 hours of monitoring. Pt was on a corometrics 256x fetal monitor through the night. At some point during the night, nurses were unable to pick up fetal heart tones. Physician was called and arrived at hospital. Physician attempted to get fetal heart tones with three different handheld dopplers. Dopplers did not pick up fetal heart tones. Physician assumed equipment error on all three dopplers. All three dopplers were checked by two separate bio-med contractors, with defects found in two of the three. In addition, pt was transferred to a corometrics 115 fetal monitors around 6 am on (b)(6) 2011. This monitor still did not pick up fetal heart tones. Both corometrics monitors have been checked by two separate bio-med contractors. The 256x checked out fine, but the 115 did not. Other products involved: handheld mini dopplers: nicolet model 100. Huntleigh model d500. These two items were checked by 2 bio-med companies and did not pass either. Diagnosis: labor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019156 |
| MDR Report Key | 1976067 |
| Date Received | 2011-01-25 |
| Date of Report | 2011-01-25 |
| Date of Event | 2011-01-21 |
| Date Added to Maude | 2011-02-01 |
| 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 | 3 |
| 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 | COROMETRICS |
| Generic Name | FETAL HEART MONITOR |
| Product Code | HEL |
| Date Received | 2011-01-25 |
| Model Number | 115 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COROMETRICS |
| Brand Name | HANDHELD MINI DOPPLER |
| Generic Name | HANDHELD MINI DOPPLER |
| Product Code | IYN |
| Date Received | 2011-01-25 |
| Model Number | D500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | HUNTLEIGH |
| Brand Name | HANDHELD MINI DOPPLERS |
| Generic Name | HANDHELD MINI DOPPLERS |
| Product Code | IYN |
| Date Received | 2011-01-25 |
| Model Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | NICOLET |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-01-25 |