FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 THERAPY I
MDR report key: 3905816
·
Received May 29, 2014
Report
- Report Number
- 9615050-2014-03723
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Date of Event
- January 1, 2014
- Report Date
- April 17, 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
- NL
- 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 OF "STARTS BEEPING WHILE RUNNING. BEEPING CAN ONLY BE STOPPED BY REMOVING THE BATTERY." NO ADD'L INFO WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, LEAKAGE WAS NOTED FROM THE DIAGNOSABLE BATTERIES IN THE BATTERY COMPARTMENT OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317399 | GEMSTAR 7 THERAPY I | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |