MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-29 for FETAL MONITOR BT-350 manufactured by Bistos Co., Ltd..
[98663953]
Fetal monitors/cardiotocogram machines of manufacturer: bistos co. , ltd model bt-350 with fda no. (b)(4) were installed with central monitoring system at (b)(6) hospital (b)(6) on (b)(6) 2017. User reported of burns at mother site where toco sensors were placed on (b)(6) 2017. The event was reported to manufacturer and few toco sensors were replaced. On (b)(6) 2018 more events of burns were reported with us and toco sensors, also the user reported for false readings of fhr in machines even without placing the us sensor at actual fetus location. Manufacturer was reported of these events and no resolution is made till date. Further use of machines is suspended due to life threatening issues concerned with fetus because machines are giving false readings that may be considered as actual observing on central monitor and could not alert the user department for any distress or emergency situation of fetus that may lead to uterine death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074946 |
| MDR Report Key | 7227791 |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-26 |
| Date of Event | 2018-01-04 |
| Date Added to Maude | 2018-01-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FETAL MONITOR |
| Generic Name | TRANSDUCER, ULTRASONIC, OBSTERIC |
| Product Code | HGL |
| Date Received | 2018-01-29 |
| Model Number | BT-350 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BISTOS CO., LTD. |
| Brand Name | FETAL MONITOR |
| Generic Name | TRANSDUCER, ULTRASONIC, OBSTERIC |
| Product Code | HGL |
| Date Received | 2018-01-29 |
| Model Number | BT-350 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BISTOS CO., LTD. |
| Brand Name | FETAL MONITOR |
| Generic Name | TRANSDUCER, ULTRASONIC, OBSTERIC |
| Product Code | HGL |
| Date Received | 2018-01-29 |
| Model Number | BT-350 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | BISTOS CO., LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2018-01-29 |