FDA Adverse Event
Malfunction
Summary report: N
SONICAID
MDR report key: 3110552
·
Received April 11, 2013
Report
- Report Number
- 1000589001-2013-00003
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Manufacturer
- HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS
- Product Code
- HEL
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
ARJOHUNTLEIGH, INC. IS SUBMITTING THE REPORT ON BEHALF OF HUNTLEIGH HEALTHCARE LTD. (B)(4).
Description of Event or Problem · 1
(B)(4)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156284 | SONICAID | FM800 RANGE OF FETAL MONITORS | HEL | HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |