FDA Adverse Event
Malfunction
Summary report: N
PCA PLS II
MDR report key: 1931169
·
Received November 11, 2010
Report
- Report Number
- 2921482-2010-00879
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 14, 2010
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K912928
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL TESTING OF THE DEVICE WAS CONDUCTED AT THE USER FACILITY BY THE FIELD SERVICE ENGINEER ON (B)(4) 2010. THE PT PENDANT IS EXPECTED TO BE RETURNED FOR FURTHER TESTING. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.(B)(4).
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE INTERMITTENTLY DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PCA PLS II | 80FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |