FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 SP NEW
MDR report key: 3962831
·
Received June 13, 2014
Report
- Report Number
- 9615050-2014-04010
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- May 8, 2014
- Report Date
- May 8, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K083019
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY THE DEVICE HAD A CONSTANT OCCLUSION ALARM ERROR. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER, DEVICE PRESSURES SENSOR DRIFT WAS FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351277 | GEMSTAR 7 SP NEW | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |