FDA Adverse Event
Death
Summary report: N
CX50 ULTRASOUND SYSTEM
MDR report key: 6010932
·
Received October 7, 2016
Report
- Report Number
- 3019216-2016-00036
- Event Type
- Death
- Date Received
- October 7, 2016
- Report Date
- October 6, 2016
- Manufacturer
- PHILIPS ULTRASOUND, INC
- Product Code
- ITX
- PMA / PMN Number
- K081802
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS CURRENTLY IN PROGRESS AND RESULTS WILL BE INCLUDED IN A FOLLOW UP REPORT UPON INVESTIGATION COMPLETION.
Additional Manufacturer Narrative · 1
THE INVESTIGATION IDENTIFIED THAT THE CUSTOMER HAD LEFT THE SYSTEM ON BATTERY POWER WHICH DRAINED THE BATTERY PRIOR TO THIS EVENT. THIS RESULTED IN THE INABILITY FOR THE SYSTEM TO POWER UP FOR NEXT USE. THERE WAS NO SYSTEM MALFUNCTION IDENTIFIED DURING THE INVESTIGATION.
Description of Event or Problem · 1
A CUSTOMER REPORTED THE INABILITY TO SCAN A PATIENT USING AN ULTRASOUND SYSTEM THAT FAILED TO TURN ON. AN UNBORN CHILD DIED PROCEEDING THE ATTEMPTED USE OF THE ULTRASOUND SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662740 | CX50 ULTRASOUND SYSTEM | TRANSDUCER, ULTRASONIC, DIAGNOSTIC | ITX | PHILIPS ULTRASOUND, INC | 795064 | SGN1100336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |