FDA Adverse Event
Malfunction
Summary report: N
GEMSTR 7 THPY ALT ST
MDR report key: 3894364
·
Received April 23, 2014
Report
- Report Number
- 9615050-2014-02912
- Event Type
- Malfunction
- Date Received
- April 23, 2014
- Date of Event
- March 26, 2014
- Report Date
- March 26, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K060806
- Removal / Correction Number
- Z-1169-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTING AN INVESTIGATION FOUND LEAKAGE 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 CUSTOMER CONTACT REPORTED THAT DURING ROUTINE TESTING AT THE USER FACILITY, LEAKAGE FROM THE DISPOSABLE BATTERIES WAS NOTED IN THE BATTERY COMPARTMENT OF THE DEVICE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245874 | GEMSTR 7 THPY ALT ST | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |