MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-22 for 259CX CTG MONITOR manufactured by Wipro Ge Healthcare Private Ltd..
[142687716]
Ge healthcare?? S investigation into the reported occurrence is ongoing. A follow-up report will be issued when the investigation has been completed. Patient information could not be obtained due to country privacy laws. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
Patient Sequence No: 1, Text Type: N, H10
[142688177]
The hospital reported an alleged failure of the fetal monitor to re-alarm for a low fetal heart rate. The fetus was stillborn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617277-2019-00001 |
| MDR Report Key | 8537514 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-22 |
| Date of Report | 2019-08-02 |
| Date Mfgr Received | 2019-07-10 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2019-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN SZALINSKI |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 259CX CTG MONITOR |
| Generic Name | SYSTEM, MONITORING, PERINATAL |
| Product Code | HGM |
| Date Received | 2019-04-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WIPRO GE HEALTHCARE PRIVATE LTD. |
| Manufacturer Address | 4, KADUGODI INDUSTRIAL AREA, BANGALORE 560067 IN 560067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-04-22 |