FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER REFUR
MDR report key: 4110055
·
Received September 11, 2014
Report
- Report Number
- 9615050-2014-05171
- Event Type
- Malfunction
- Date Received
- September 11, 2014
- Date of Event
- January 1, 2014
- Report Date
- August 20, 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 YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY IT WAS NOTED THAT THE DEVICE DID NOT PASS THE VOLUME ALARM TEST AT THE LOW END. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 563118 | PLUM A+ DRIVER REFUR | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE: LIST #UNK, SN UNK |