FDA Adverse Event
Malfunction
Summary report: N
OPTIVANTAGE WITH PEDESTAL
MDR report key: 3221842
·
Received July 9, 2013
Report
- Report Number
- 1518293-2013-00141
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 17, 2013
- Report Date
- July 9, 2013
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- DXT
- PMA / PMN Number
- K042744
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
ON (B)(6) 2013 CUSTOMER CALLED US ON AN OPTIVANTAGE (B)(4). A CLEANING WORKER GOT AN ELECTRIC SHOCK. SHE IS FINE. OUR ENGINEER VISITED THE CUSTOMER AND CHECKED THE UNIT TOGETHER WITH THE IN HOUSE TECHNICAL DEPARTMENT. THE OPTIVANTAGE IS OKAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312553 | OPTIVANTAGE WITH PEDESTAL | DXT | LIEBEL-FLARSHEIM CO. | OPTIVANTAGE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |