FDA Adverse Event
Malfunction
Summary report: N
PLUM XL3M W/NURS CAL
MDR report key: 1880888
·
Received October 4, 2010
Report
- Report Number
- 2921482-2010-00758
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 9, 2010
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K952799
- 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 ON 09/09/2010, AT THE USER FACILITY BY THE HOSPIRA FIELD SERVICE ENGINEER. THE AC POWER CORD WAS RECEIVED 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 PRONGS ON THE AC POWER CORD WERE BENT. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM XL3M W/NURS CAL | 80FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |