FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER ED 2
MDR report key: 2091548
·
Received April 6, 2011
Report
- Report Number
- 9615050-2011-00235
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 10, 2011
- 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4)
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING THE INCOMING INSPECTION, PRIOR TO CLINICAL USE, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM A+ DRIVER ED 2 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | (B)(4)| PLUM A+ SOFTWARE MODULE: LIST #20791 |