FDA Adverse Event
Malfunction
Summary report: N
PLM A+ INTL ENG VII
MDR report key: 4110530
·
Received September 16, 2014
Report
- Report Number
- 9615050-2014-05242
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 8, 2014
- Report Date
- August 27, 2014
- 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
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 THE DEVICE ALARMED WITH AN E321 (BATTERY CHARGER TIMEOUT) ERROR CODE. NO SPECIFIC PT INFORMATION, DEVICE PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573951 | PLM A+ INTL ENG VII | 80FRN | FRN | HOSPIRA COSTA RICA LTD | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PLUM A+ SOFTWARE MODULE, LIST # UNK, SN UNK |