FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 THERAPY IN
MDR report key: 3843470
·
Received March 14, 2014
Report
- Report Number
- 9615050-2014-01950
- Event Type
- Malfunction
- Date Received
- March 14, 2014
- Date of Event
- February 1, 2014
- Report Date
- February 6, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K083019
- Removal / Correction Number
- Z-1170-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING TESTING, LEAKAGE WAS NOTED FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT OF THE DEVICE. THE DEVICE HAS BEEN IDENTIFIED AS PART OF A PRODUCT RECALL. THIS REPORT REPRESENTS ALL THE INFO 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 WAS GIVING A CALL FOR SERVICE". NO ADD'L INFO WAS PROVIDED. THIS IS NOT A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, LEAKAGE WAS NOTED FROM THE DISPOSABLE BATTERIES IN THE BATTERY COMPARTMENT OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153722 | GEMSTAR 7 THERAPY IN | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |