FDA Adverse Event
Death
Summary report: N
SYSTEM 83 PLUS
MDR report key: 5522615
·
Received March 24, 2016
Report
- Report Number
- 3007082252-2016-00007
- Event Type
- Death
- Date Received
- March 24, 2016
- Report Date
- May 17, 2016
- Manufacturer
- CUSTOM ULTRASONICS INC.
- Product Code
- FEB
- PMA / PMN Number
- K983017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS DENIED THAT THE SYSTEM 83 PLUS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AS ALLEGED IN THE LEGAL DOCUMENTS. THE AER USED AT THIS FACILITY IS LIKELY A MEDIVATOR'S AUTOMATIC ENDOSCOPE REPROCESSOR.
Additional Manufacturer Narrative · 1
IT WAS CONFIRMED THAT CUSTOM ULTRASONICS INC., NEVER SOLD ITS SYSTEM 83 PLUS DEVICE TO THE FACILITY MENTIONED IN THE PLAINTIFF'S COMPLAINT. THE ACTION AGAINST CUSTOM ULTRASONICS INC. HAS BEEN DISMISSED. THE DISMISSAL WAS ENTERED ON (B)(6) 2016.
Description of Event or Problem · 1
ADVERSE EVENT AS ALLEGED SOLELY LEGAL DOCUMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179990 | SYSTEM 83 PLUS | ENDOSCOPE WASHER DISINFECTOR | FEB | CUSTOM ULTRASONICS INC. | UNKNOWN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |