FDA Adverse Event
Malfunction
Summary report: N
PLUM LC 500 REFURB
MDR report key: 3231104
·
Received July 12, 2013
Report
- Report Number
- 9615050-2013-02039
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- October 8, 2012
- Report Date
- November 5, 2012
- Manufacturer
- HOSPIRA HOLDINGS DE COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K911401
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE DOOR ROLLER AND DOOR ROLLER PIN WERE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324787 | PLUM LC 500 REFURB | 80 FRN | FRN | HOSPIRA HOLDINGS DE COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |