FDA Adverse Event
Death
Summary report: N
SONICAID
MDR report key: 1904497
·
Received November 8, 2010
Report
- Report Number
- 1000589001-2010-00001
- Event Type
- Death
- Date Received
- November 8, 2010
- Date of Event
- October 4, 2010
- Report Date
- October 11, 2010
- Manufacturer
- HUNTLEIGH HEALTHCARE LTD DIAGNOSTICS
- Product Code
- HGM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
THE TEAMCARE UNIT WAS BEING USED TO MONITOR A MOTHER/CHILD IN AN ANTE-NATAL ENVIRONMENT. THE HEART-FREQUENCY (HEART RATE) DISPLAYED ON THE MONITOR WAS DESCRIBED AS SHAPED LIKE A SINUS-CURVE, WHICH IMMEDIATELY ALARMED THE DOCTORS. AS THE UNIT SHOWED THE MOVEMENTS OF THE CHILD, WHICH WERE SOMETIMES VERY STRONG, THE DOCTORS ASSUMED THAT THE CHILD AT LEAST WAS IN GOOD HEALTH. HOWEVER, AT A TIME LATER, THE DOCTORS THEN DISCOVERED THAT THE CHILD WAS ACTUALLY STILLBORN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONICAID | TEAM FETAL MONITORS | HGM | HUNTLEIGH HEALTHCARE LTD DIAGNOSTICS | TEAMCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |