FDA Adverse Event
Malfunction
Summary report: N
PLM A+ SPANISH 220V
MDR report key: 3770806
·
Received February 18, 2014
Report
- Report Number
- 9615050-2014-01254
- Event Type
- Malfunction
- Date Received
- February 18, 2014
- Date of Event
- January 23, 2014
- Report Date
- January 23, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K070398
- Removal / Correction Number
- FA212-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER PERFORMED PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY. DURING TESTING, THE FLUID SHIELD WAS FOUND TO BE DAMAGED AND FLUID SPILLAGE WAS NOTED. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE FLUID SHIELD WAS FOUND TO BE DAMAGED AND FLUID SPILLAGE WAS NOTED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN 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 |
|---|---|---|---|---|---|---|---|
| 101750 | PLM A+ SPANISH 220V | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE, LIST #UNK, SN UNK |