FDA Adverse Event
Malfunction
Summary report: N
PLM A+ PLATINUM
MDR report key: 4143037
·
Received September 12, 2014
Report
- Report Number
- 9615050-2014-05214
- Event Type
- Malfunction
- Date Received
- September 12, 2014
- Date of Event
- January 1, 2014
- Report Date
- August 26, 2014
- Manufacturer
- HOSPIRA HOLDINGS COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K070398
- Removal / Correction Number
- NA
- 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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING TESTING AT THE USER FACILITY, IT WAS NOTED THE BATTERY WAS SWOLLEN. THE BIOMEDICAL DEPARTMENT REPORTED THAT THE DEVICE WOULD NOT RUN ON BATTERY POWER. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565336 | PLM A+ PLATINUM | 80FRN | FRN | HOSPIRA HOLDINGS COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE, LIST # UNK, SN UNK |