FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR PAIN MGE SNG
MDR report key: 3832188
·
Received March 7, 2014
Report
- Report Number
- 9615050-2014-01755
- Event Type
- Malfunction
- Date Received
- March 7, 2014
- Date of Event
- January 31, 2014
- Report Date
- February 5, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K060806
- Removal / Correction Number
- Z-1159-2013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TESTING AND INVESTIGATION FOUND THE DEVICE ALARMED FOR 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE CODE ALARM . 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, THE DEVICE ALARMED WITH A 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE ALARM CODE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 138665 | GEMSTAR PAIN MGE SNG | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |