FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR PAIN MGE SNG
MDR report key: 3378036
·
Received August 30, 2013
Report
- Report Number
- 9615050-2013-02642
- Event Type
- Malfunction
- Date Received
- August 30, 2013
- Date of Event
- June 11, 2013
- Report Date
- July 31, 2013
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K060806
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 THE DEVICE ALARMED WITH A 11/004 (LESS THAN 2.0 VOLTS ON LITHIUM BATTERY) SERVICE ALARM CODE. THE PUMP WAS RETURNED TO THE BIOMEDICAL DEPARTMENT WITH A NOTE THAT INDICATED ERROR 18/000/000 AND 11/004/031 CHARGER DOCK - NO POWER. THE CUSTOMER CONTACT INDICATED THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430629 | GEMSTAR PAIN MGE SNG | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |