FDA Adverse Event
Malfunction
Summary report: N
PLUM 1.6 W/DATAPORT
MDR report key: 2802410
·
Received October 18, 2012
Report
- Report Number
- 9615050-2012-01250
- Event Type
- Malfunction
- Date Received
- October 18, 2012
- Date of Event
- September 21, 2012
- Report Date
- September 21, 2012
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K911401
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION 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, IT WAS NOTED THAT THE GROUND PRONG ON THE AC POWER CORD PLUG WAS BROKEN. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM 1.6 W/DATAPORT | 80 | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |