FDA Adverse Event
Malfunction
Summary report: N
PLM A+ PLATINUM
MDR report key: 3822916
·
Received February 5, 2014
Report
- Report Number
- 9615050-2014-00902
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- January 10, 2014
- Report Date
- January 10, 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
- AR, 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 THAT DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74827 | PLM A+ PLATINUM | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE, LIST #UNK, SN UNK |