FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER ED 2
MDR report key: 3022995
·
Received March 21, 2013
Report
- Report Number
- 9615050-2013-00460
- Event Type
- Malfunction
- Date Received
- March 21, 2013
- Date of Event
- February 25, 2013
- Report Date
- February 27, 2013
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K042081
- Removal / Correction Number
- Z-0624-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TESTING AND INVESTIGATION FOUND THE DEVICE HAD UNRESTRICTED FLOW WHEN THE DOOR WAS OPENED. THIS WAS DUE TO THE DEVICE DOOR ROLLER WAS MISSING AND THE ROLLER PIN WAS BROKEN OFF. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE SERVICE CENTER, UNRESTRICTED FLOW WAS NOTED WHEN THE DOOR WAS OPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118987 | PLUM A+ DRIVER ED 2 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE, LIST #20791, SN (B)(4) |