FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER NEW
MDR report key: 3822832
·
Received February 7, 2014
Report
- Report Number
- 9615050-2014-01013
- Event Type
- Malfunction
- Date Received
- February 7, 2014
- Date of Event
- January 9, 2014
- Report Date
- January 9, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K042081
- Removal / Correction Number
- FA210-07
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTING AND EVALUATION FOUND THAT THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80946 | PLUM A+ DRIVER NEW | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | LIST #20791,| SN (B)(4)| PLUM A+ SOFTWARE MODULE, |