FDA Adverse Event
Malfunction
Summary report: N
PLM A+ PLATINUM MODU
MDR report key: 2891487
·
Received December 6, 2012
Report
- Report Number
- 9615050-2012-01475
- Event Type
- Malfunction
- Date Received
- December 6, 2012
- Date of Event
- November 2, 2012
- Report Date
- November 7, 2012
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K070398
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. 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 CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE INTERMITTENTLY DID NOT SOUND AN AUDIBLE ALARM TONE. IT WAS REPORTED THAT ERROR CODE E301 (AUDIO ALARM FAILURE) WAS DISPLAYED. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLM A+ PLATINUM MODU | 80 | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | LIST #20677, SN (B)(4)| PLUM A+ SOFTWARE MODULE |