FDA Adverse Event
Malfunction
Summary report: N
PLM A+ HSP PRG PLG P
MDR report key: 4152550
·
Received October 6, 2014
Report
- Report Number
- 9615050-2014-05490
- Event Type
- Malfunction
- Date Received
- October 6, 2014
- Date of Event
- January 1, 2014
- Report Date
- September 17, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K052052
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER PERFORMED INITIAL TESTING AT THE USER FACILITY. THE PIEZO IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT PASS THE AUDIO TEST. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622134 | PLM A+ HSP PRG PLG P | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE, LIST #UNK, SN UNK |