FDA Adverse Event
Malfunction
Summary report: N
PLM A+PMP W/BSE MOD
MDR report key: 4460726
·
Received January 23, 2015
Report
- Report Number
- 9615050-2015-00163
- Event Type
- Malfunction
- Date Received
- January 23, 2015
- Date of Event
- June 25, 2014
- Report Date
- June 25, 2014
- Manufacturer
- HOSPIRA HOLDINGS DE COSTA RICA LTD.
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 DISPLAYED "DISTAL OCCLUSION DELIVERY". THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, IT WAS NOTED THAT THE DEVICE CLOSER REGULATOR WAS NOT MOUNTED PROPERLY IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53852 | PLM A+PMP W/BSE MOD | 80FRN | FRN | HOSPIRA HOLDINGS DE COSTA RICA LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PLUM A+ SOFTWARE MODULE, LIST #12097,(B)(4) |