FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ DRIVER REFUR
MDR report key: 3872506
·
Received April 18, 2014
Report
- Report Number
- 9615050-2014-02786
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Date of Event
- January 1, 2012
- Report Date
- August 17, 2012
- 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
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL TESTING AT THE USER FACILITY OCCURRED ON 08/20/2012. THE DEVICE WAS NOT RETURNED TO THE SERVICE CENTER FOR FURTHER TESTING. HOSPIRA COULD NOT COMPLETE THE TESTING AND INVESTIGATION ON THE DEVICE ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT IS BEING MADE AS PART OF A RETROSPECTIVE REVIEW. NO FURTHER TESTING OR INVESTIGATION WILL BE PERFORMED. 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, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238738 | 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 # 20791,| SN (B)(4) |