FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR PAIN MGE SNG
MDR report key: 3983223
·
Received July 3, 2014
Report
- Report Number
- 9615050-2014-04304
- Event Type
- Malfunction
- Date Received
- July 3, 2014
- Date of Event
- June 6, 2014
- Report Date
- June 9, 2014
- 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
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 REPORT FROM THE CUSTOMER CONTACT THAT DURING PREVENTATIVE MAINTENANCE TESTING THE DEVICE ALARMED WITH ERROR CODE 18/000/000 (HISTORY POINTER ERROR). THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CTR, BATTERY LEAKAGE WAS NOTED IN THE BATTERY COMPARTMENT AND MIDDLE PRINTED CIRCUIT BOARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392358 | GEMSTAR PAIN MGE SNG | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |