FDA Adverse Event
Malfunction
Summary report: N
PLUM XLM W/DATAPORT
MDR report key: 1930449
·
Received November 18, 2010
Report
- Report Number
- 2921482-2010-00912
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 2010
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K010924
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
INITIAL TESTING OF THE DEVICE WAS CONDUCTED AT THE USER FACILITY ON (B)(4) 2010 BY THE HOSPIRA FIELD SERVICE ENGINEER. THE POWER CORD IS EXPECTED TO BE RETURNED FOR FURTHER TESTING. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE GROUND PIN ON THE AC POWER CORD PLUG WAS BENT. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM XLM W/DATAPORT | 80FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |