FDA Adverse Event
Malfunction
Summary report: N
PLM A+ PLATINUM MODU
MDR report key: 3963309
·
Received June 19, 2014
Report
- Report Number
- 9615050-2014-04087
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- January 1, 2014
- Report Date
- May 29, 2014
- 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
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE POWER CORD IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE GROUND PRONG ON THE AC POWER CORD WAS BROKEN. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359163 | PLM A+ PLATINUM MODU | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE, LIST #12097, SN UNK |