FDA Adverse Event
Malfunction
Summary report: N
APLUM A+ DRIVER 13.4
MDR report key: 3161938
·
Received June 3, 2013
Report
- Report Number
- 9615050-2013-01483
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 10, 2013
- Report Date
- April 16, 2013
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K042081
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 VERIFICATIONS TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DOOR ROLLER WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 242907 | APLUM A+ DRIVER 13.4 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PLUM A+ SOFTWARE MODULE, LIST #20791, SN (B)(4) |