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 |