FDA Adverse Event
Malfunction
Summary report: N
LC PCA SW VERSION 1
MDR report key: 3970762
·
Received April 29, 2014
Report
- Report Number
- 9615050-2014-03067
- Event Type
- Malfunction
- Date Received
- April 29, 2014
- Date of Event
- March 18, 2014
- Report Date
- March 18, 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
- CA, US
- Reporter Occupation
- OTHER
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 DEVICE WAS RETURNED TO THE SERVICE CENTER FOR A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE DID NOT PASS THE ELECTRICAL SAFETY TEST. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE GROUND PRONG ON THE AC POWER CORD WAS LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256325 | LC PCA SW VERSION 1 | 80MEA | MEA | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |