FDA Adverse Event
Malfunction
Summary report: N
PLM A+ PALNTINUM
MDR report key: 4180531
·
Received October 15, 2014
Report
- Report Number
- 9615050-2014-05637
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 16, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K070398
- Removal / Correction Number
- FA212-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING TESTING, IT WAS NOTED THAT THE DEVICE DISTAL PRESSURE SENSOR PIN WAS BROKEN. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. 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 WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE ALARMED WITH AN N184 (NEG PROX OCCL A NONDELIVERY). NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DISTAL PRESSURE PIN WAS FOUND TO BE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654506 | PLM A+ PALNTINUM | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |