FDA Adverse Event
Malfunction
Summary report: N
PLMA DVC V11.51 1 N
MDR report key: 3061236
·
Received April 10, 2013
Report
- Report Number
- 9615050-2013-00660
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- January 1, 2013
- Report Date
- March 13, 2013
- 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
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. 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 CUSTOMER CONTACT REPORTED THE DEVICE ALARMED WITH E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. ON AN UNSPECIFIED DATE AND TIME, DURING TRAINING AT THE USER FACILITY, THE DEVICE ALARMED WITH E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF 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 |
|---|---|---|---|---|---|---|---|
| 149990 | PLMA DVC V11.51 1 N | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | BA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | SN (B)(4)| PLUM A+ SOFTWARE MODULE: LIST #12097 |