MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for MONICA FETAL MONITORING SYSTEM GTIN(01): 05060433670053 manufactured by Monica Healthcare Ltd..
[129775682]
The nurse removed the wireless monica monitoring system from the patient's abdomen as it kept alarming -stating to adjust electrode. Upon removal of the electrodes, the nurse found the skin was reddened and inflamed. There was one electrode on the patient's left side that was an abrasion and was blood tinged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081895 |
| MDR Report Key | 8138920 |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-11-21 |
| Date Added to Maude | 2018-12-06 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONICA FETAL MONITORING SYSTEM |
| Generic Name | SYSTEM, MONITORING, PERINATAL |
| Product Code | HGM |
| Date Received | 2018-12-05 |
| Model Number | GTIN(01): 05060433670053 |
| Lot Number | (10):500904 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONICA HEALTHCARE LTD. |
| Manufacturer Address | NOTTINGHAM NG 105QG UK NG 10 5QG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-05 |