FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER NEW 8
MDR report key: 4142976
·
Received September 12, 2014
Report
- Report Number
- 9615050-2014-05211
- Event Type
- Malfunction
- Date Received
- September 12, 2014
- Date of Event
- January 1, 2014
- Report Date
- August 26, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K042081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THE DEVICE ALARMS BATTERY DEAD WILL NOT RUN ON BATTERY POWER. THERE WERE NO REPORTS OF ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, THE DEVICE WAS NOTED TO HAVE A SWOLLEN BATTERY DURING BATTERY CHANGE. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565415 | PLUM A+ DRIVER NEW 8 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |