FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER NEW
MDR report key: 3061219
·
Received April 10, 2013
Report
- Report Number
- 9615050-2013-00658
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- February 26, 2013
- Report Date
- February 27, 2013
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K042081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DURING TESTING, IT WAS FOUND THAT THE DEVICE DOOR ROLLER WAS BROKEN. AS INDICATED, THE DEVICE HAS BEEN IDENTIFIED AS PART OF THE PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION 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 WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153391 | PLUM A+ DRIVER NEW | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | SN (B)(4)| PLUM A+ SOFTWARE MODULE: LIST #20791 |