FDA Adverse Event
Malfunction
Summary report: N
PLM A+ SPANISH DEVIC
MDR report key: 3832797
·
Received March 17, 2014
Report
- Report Number
- 9615050-2014-02005
- Event Type
- Malfunction
- Date Received
- March 17, 2014
- Date of Event
- February 18, 2014
- Report Date
- February 18, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K070398
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE DOES NOT WORK. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, EVIDENCE OF ELECTRICAL SPARKING WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156973 | PLM A+ SPANISH DEVIC | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PLUM A+ SOFTWARE MODULE: LIST #20791, SN (B)(4) |