FDA Adverse Event
Malfunction
Summary report: N
GEMSTAR BOLUSCORD (EACH)
MDR report key: 3061468
·
Received April 10, 2013
Report
- Report Number
- 3008785455-2013-00027
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 12, 2013
- Manufacturer
- HOSPIRA INC.
- Product Code
- FRN
- PMA / PMN Number
- K060806
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE SERVICE CENTER, THE DEVICE INTERMITTENTLY DID NOT DELIVER WHEN THE BOLUS BUTTON WAS PRESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148344 | GEMSTAR BOLUSCORD (EACH) | 80 FRN | FRN | HOSPIRA INC. | NA | UNKG1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |