FDA Adverse Event
Malfunction
Summary report: N
LC PCA HOSPIRA MEDNE
MDR report key: 4142661
·
Received September 26, 2014
Report
- Report Number
- 9615050-2014-05389
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- August 25, 2014
- Report Date
- September 9, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- MEA
- PMA / PMN Number
- K042800
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 DURING PREVENTIVE MAINTENANCE AT THE USER FACILITY, THE DEVICE AUDIBLY ALARMED ERROR 630 (SCREW ROTATION ERROR). THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600614 | LC PCA HOSPIRA MEDNE | 80MEA | MEA | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |