FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR 7 SP REFURB
MDR report key: 3960609
·
Received June 20, 2014
Report
- Report Number
- 9615050-2014-04101
- Event Type
- Malfunction
- Date Received
- June 20, 2014
- Date of Event
- April 11, 2014
- Report Date
- May 15, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD
- Product Code
- FRN
- PMA / PMN Number
- K083019
- Removal / Correction Number
- FA302-02
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING TESTING AND INVESTIGATION AT THE SERVICE CENTER THE DEVICE ALARMED WITH A CHECK CASSETTE P ALARM CODE DURING THE DELIVERY ACCURACY AND PROXIMAL OCCLUSION TEST. THE PROBABLE CAUSE WAS DUE TO A PROXIMAL PRESSURE SENSOR CALIBRATION DRIFT. THIS 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 DEVICE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT FROM THE CUSTOMER CONTACT THAT THE DEVICE ALARMED WITH ERROR CODE CHECK CASSETTE P. THIS DID NOT INDICATE A REPORTABLE MALFUNCTION. HOWEVER, DURING VERIFICATION TESTING AT THE SERVICE CENTER IT WAS FOUND THE DEVICE PRESSURE SENSOR HAD DRIFTED OUT OF CALIBRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363555 | GEMSTAR 7 SP REFURB | 80FRN | FRN | HOSPIRA COSTA RICA LTD | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |