FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR PAIN MGE SNG
MDR report key: 1547495
·
Received November 12, 2009
Report
- Report Number
- 2921482-2009-00392
- Event Type
- Malfunction
- Date Received
- November 12, 2009
- Date of Event
- October 1, 2009
- Report Date
- October 16, 2009
- Manufacturer
- HOSPIRA, INC.
- Product Code
- MEA
- PMA / PMN Number
- K060806
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT OF THE DEVICE, TESTING AND INVESTIGATION COULD NOT BE PERFORMED. AT POWER UP, THE DEVICE ALARMED WITH ERROR CODE 11/004/0028 (LITHIUM BATTERY LOW). THIS WAS DUE TO A PRINTED CIRCUIT BOARD. REPAIRING THE DEVICE WOULD AFFECT TESTING RESULTS FOR THE REPORTED EVENT; THEREFORE, FURTHER TESTING COULD NOT BE PERFORMED. (B) (4)
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN AIR WAS PRESENT IN TUBING. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS 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 |
|---|---|---|---|---|---|---|---|
| 1 | GEMSTAR PAIN MGE SNG | 80FRN | MEA | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |