FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER REFUR
MDR report key: 4142979
·
Received September 12, 2014
Report
- Report Number
- 9615050-2014-05208
- Event Type
- Malfunction
- Date Received
- September 12, 2014
- Date of Event
- January 1, 2014
- Report Date
- August 25, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K042081
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE PIEZO IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT BEEN RECEIVED YET. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING TESTING AT THE USER FACILITY IT WAS NOTED THAT THE DEVICE DID NOT PASS THE VOLUME ALARM TEST AT THE LOW END. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, DEVICE PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN THE CRITICAL THERAPIES WHILE THE DEVICE WAS CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565416 | PLUM A+ DRIVER REFUR | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PLUM A+ SOFTWARE MODULE, LIST # UNK, SN UNK |