FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 SP REFURB
MDR report key: 4403106
·
Received January 7, 2015
Report
- Report Number
- 9615050-2015-00025
- Event Type
- Malfunction
- Date Received
- January 7, 2015
- Date of Event
- December 3, 2014
- Report Date
- December 4, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K083019
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE ALARMED WITH A 11/001/133 (LESS THAN 4.5 VOLTS MEASURED ON 5V LINE) SERVICE ALARM CODE. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, CORROSION FROM LEAKAGE FROM THE DISPOSABLE BATTERIES WAS NOTED ON THE MIDDLE PRINTED CIRCUIT BOARD AND METAL CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12790 | GEMSTAR 7 SP REFURB | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |