FDA Adverse Event
Malfunction
Summary report: N
PLMA V11.51 1 N
MDR report key: 4142948
·
Received September 12, 2014
Report
- Report Number
- 9615050-2014-05199
- Event Type
- Malfunction
- Date Received
- September 12, 2014
- Date of Event
- July 15, 2014
- Report Date
- August 28, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K070398
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE PASSED TESTING BY SOUNDING AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. FURTHER TESTING BY THE SUPPLIER FOUND THAT THE TRANSISTOR GAIN VALUE (BETA) OF THE TRANSISTOR, INTERNAL TO THE PIEZO, WAS NOT SUFFICIENT TO DRIVE THE PIEZO BUZZER RESULTING IN NO AUDIBLE ALARM TONE. THIS REPORT REPRESENTS ALL THE INFO 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 SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 565398 | PLMA V11.51 1 N | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | PLUM A+ SOFTWARE MODULE, LIST# 12097,| SN (B)(4) |