FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 THERAPY FR
MDR report key: 3832719
·
Received March 26, 2014
Report
- Report Number
- 9615050-2014-02299
- Event Type
- Malfunction
- Date Received
- March 26, 2014
- Date of Event
- January 24, 2014
- Report Date
- January 27, 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING TESTING A 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 INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE SERVICE CTR WITH A REQUEST FROM THE CUSTOMER CONTACT FOR UPDATE/RECERTIFICATION OF THE DEVICE. NO ADDITIONAL INFO WAS PROVIDED. THIS DOES NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR 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 |
|---|---|---|---|---|---|---|---|
| 176469 | GEMSTAR 7 THERAPY FR | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |